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LYMPHOCURE
Dear [FDA Reviewer],
I'm writing to request approval of our New medication Application (NDA) for Lymphocure,
an experimental medication for the treatment of relapsed or refractory Acute Lymphocytic
Leukemia (ALL). Lymphocure is a new immunotherapy drug that uses the immune system's
capacity to target cancer cells and trigger immune-mediated death.
We think Lymphocure has the potential to be of great help to individuals with relapsed or
refractory ALL, for whom therapy choices are restricted. Our preclinical studies show that
Lymphocure can bind to CD19 and CD20 receptors on cancer cells and promote immune-
mediated death. Lymphocure was demonstrated to be effective in lowering tumor burden in
both xenograft and syngeneic ALL models in both in vitro and in vivo settings.
A single-arm, multicenter phase II investigation in patients with relapsed or refractory ALL is
included in our planned clinical trial design. The study's primary aim is objective response
rate (ORR), with secondary objectives including duration of response, progression-free
survival (PFS), overall survival (OS), and safety. This trial design, we feel, is appropriate for
assessing the effectiveness and safety of Lymphocure in this patient group.
We conducted thorough preclinical toxicity investigations in rats and nonhuman primates,
demonstrating Lymphocure's safety and tolerability at dosages up to ten times the intended
therapeutic dose. Mild to moderate alterations in hematology and clinical chemistry
parameters, including temporary declines in white blood cell counts and elevations in liver
enzymes, were the predominant toxicological results.
We appreciate the opportunity to submit our research and discuss the development of
Lymphocure with the FDA. We think Lymphocure represents a substantial development in
the treatment of relapsed or refractory ALL, and we look forward to collaborating with the
FDA to provide this critical medicine to patients in need.
Sincerely,
Hema Anantha Harshitha Nalam
Rushikesh Reddy Nandireddy
Sahithi Swarna
Sahithi Puja Uppaluru
Sai Ram Yadlapalli
Boston, MA
Agenda:
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LYMPHOCURE
Lymphocure introduction and summary: Provide a brief review of the medicine and its
intended application for the treatment of relapsed or refractory ALL. Discuss the patient
population's unmet medical needs and the possible advantages of Lymphocure.
Toxicology research and preclinical data: Examine the preclinical data and toxicity studies
done in rats and nonhuman primates, including Lymphocure's mode of action and the drug's
safety and tolerability profile.
Provide a summary of the planned Lymphocure clinical trial design, including the patient
population, study objectives, and statistical analysis strategy.
Discussion of any available
comparison data with licensed medications for the treatment of relapsed or refractory ALL.
Questions for the FDA: Request comments and direction from the FDA on critical
development concerns such as study design, patient selection criteria, and clinical outcomes.
Specific inquiries may include:
Are the proposed criteria for inclusion and exclusion suitable for the patient population?
Is ORR alone sufficient to demonstrate efficacy, or should other endpoints be considered?
Should the clinical study contain a comparison arm, and if yes, which comparator is best?
Following steps: Discuss the future stages in the development of Lymphocure, such as the
timing for submitting new data and the FDA approval procedure.
Conclusion: Thank you for your time and insight, and please repeat the company's
commitment to discovering safe and effective therapies for patients with relapsed ALL.
Company:
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LYMPHOCURE
XYZ Pharmaceuticals, a biopharmaceutical firm focused on creating novel medicines for
cancer and other critical diseases, is developing Lymphocure. The firm was established in
2005 and is based in San Francisco, California.
Background:
Lymphocure is a new small molecule inhibitor of BTK, a crucial enzyme in the B-cell
receptor signaling pathway involved in B-cell survival and proliferation. Lymphocure is
intended to decrease the proliferation and survival of malignant B-cells in patients with
relapsed or refractory ALL by inhibiting BTK.
Preclinical investigations have shown that Lymphocure is highly selective for BTK and has
substantial anticancer action in vitro and in vivo against ALL cell lines. Furthermore,
Lymphocure demonstrated a positive safety profile in preclinical toxicological investigations
in rats and nonhuman primates.
Lymphocure is now being tested in a phase 1 clinical trial in patients with relapsed or
refractory ALL, with early findings expected in the next 6-12 months. The trial's goal is to
assess Lymphocure's safety, tolerability, and preliminary effectiveness as a single drug in this
patient group. If the phase 1 study findings are positive, the business intends to launch a
pivotal phase 2/3 trial to support regulatory approval of Lymphocure.
Product Information
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LYMPHOCURE
Lymphocure, as a fictitious medicine, has no comparison research with licensed drugs.
Potential comparison studies, depending on the mechanism of action and current data on
other CD19-targeted treatments, might include:
Blinatumomab vs. Lymphocure: Blinatumomab is a CD19-targeted therapeutic licensed for
the treatment of relapsed or refractory ALL. In patients with relapsed or refractory ALL, a
comparison trial might compare the safety and effectiveness of Lymphocure vs
Blinatumomab.
Lymphocure combined with chemotherapy vs. chemotherapy alone: The current standard of
treatment for ALL is chemotherapy, and some chemotherapy regimens include CD19-targeted
medicines. In newly diagnosed patients with ALL, a comparison research might compare the
safety and effectiveness of adding Lymphocure to conventional treatment vs chemotherapy
alone.
Lymphocure vs Hematopoietic stem cell transplantation (HSCT): HSCT is a potentially
curative therapeutic option for certain ALL patients, but it is fraught with dangers and
problems. A research comparing the safety and effectiveness of Lymphocure against HSCT in
patients with relapsed or refractory ALL who are suitable for both therapies might be
conducted.
These are only a few examples of prospective Lymphocure comparative studies in the
treatment of ALL. The particular design of comparison studies would be determined by the
study aims, patient population, and resources available.
Lymphocure's distinct traits as a fictitious medicine may be identified by its supposed
attributes and mode of action.
Lymphocure is distinguished by its new method of action, which employs a bispecific
antibody to target CD19-positive cancer cells. This method of action differs from existing
treatments for Acute Lymphocytic Leukemia (ALL), which mostly include chemotherapy and
hematopoietic stem cell transplantation.
Another distinguishing feature of Lymphocure is its ability to elicit long-lasting reactions
with low harm. Although CD19-targeted treatments have shown encouraging outcomes in the
treatment of ALL, they can cause serious adverse effects such as cytokine release syndrome
and neurotoxicity. Lymphocure's dual specificity for CD19 and T-cell receptors has the
potential to improve the efficacy and reduce the toxicity of CD19-targeted treatment.
Lymphocure might be a beneficial therapy option for individuals with relapsed or refractory
ALL if it can demonstrate safety and effectiveness in clinical studies. Lymphocure is a good
contender for FDA clearance due to its novel mode of action and potential for low toxicity,
assuming it passes all regulatory standards for safety and efficacy. Finally, the FDA will base
its judgment on the totality of clinical trial data, including the drug's safety, effectiveness, and
potential advantages above existing treatment choices.
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LYMPHOCURE
Description:
Lymphocure is a novel treatment for Acute Lymphocytic Leukemia (ALL), a kind of blood
cancer that affects lymphocytes, which are white blood cells. The medication targets and
destroys malignant lymphocytes while leaving healthy cells alone.
Phase I Clinical Trial Study Design:
The goal of this study was to assess the safety and maximum tolerated dosage of Lymphocure
in individuals with ALL.
Participants: ALL patients (n = 20)
Intervention: To examine safety and acceptability, administer Lymphocure at three different
dosages (10mg, 25mg, and 50mg).
Outcome measurements include adverse events, vital signs, laboratory tests, and
electrocardiograms.
Clinical Trial in Phase II:
The goal of this study is to determine the effectiveness and safety of Lymphocure in
individuals with ALL.
Patients with ALL (n=100) participated.
Intervention: To test effectiveness and safety, administer Lymphocure at the optimum dosage
determined in Phase I.
Outcome measurements include efficacy evaluations such as overall response rate,
progression-free survival, and overall survival, as well as safety assessments such as adverse
events, vital signs, laboratory tests, and electrocardiograms.
The goal of the Phase III clinical trial is to validate the effectiveness and safety of
Lymphocure in a broader group of patients with ALL.
Patients with ALL (n=500) took part in the study.
Intervention: To establish effectiveness and safety, administer Lymphocure at the optimum
dosage determined in Phase II.
Outcome measurements include efficacy evaluations such as overall response rate,
progression-free survival, and overall survival, as well as safety assessments such as adverse
events, vital signs, laboratory tests, and electrocardiograms.
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LYMPHOCURE
Regulatory Affairs Landscape:
Preclinical studies: Animal models are used to assess the safety and efficacy of Lymphocure
before human trials. Before Phase I trials may begin, data from these research is submitted to
regulatory authorities for assessment and permission.
Application for an Investigational New Drug (IND): Requested approval from regulatory
authorities to undertake Phase I clinical studies in people. This application contains
information on the research design and safety procedures, as well as data from preclinical
trials.
A phase I clinical trial was conducted to evaluate the safety and maximum tolerated dosage of
Lymphocure in ALL patients. Before Phase II trials may begin, data from this trial is
submitted to regulatory authorities for assessment and approval.
Lymphocure effectiveness and safety were evaluated in a phase II clinical trial in individuals
with ALL. Before Phase III trials may begin, data from this trial is submitted to regulatory
authorities for assessment and approval.
Phase III Clinical Trial: Conducted to establish Lymphocure's effectiveness and safety in a
broader group of ALL patients. Before the medicine may be licensed for commercialization,
the data from this study is submitted to regulatory authorities for assessment and approval.
NDA stands for New Drug Application. Lymphocure has been submitted to regulatory
authorities for commercial authorisation. This application contains information from
preclinical and clinical studies, as well as manufacturing, labeling, and post-marketing
surveillance plans.
Post-marketing surveillance: Ongoing monitoring of Lymphocure's safety and efficacy after it
has been approved for marketing. This involves tracking adverse occurrences and performing
more research.
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LYMPHOCURE
Mechanism of Action:
Lymphocure is a targeted treatment that works by specifically attaching to and suppressing
the expression of a particular protein called CD19 on the surface of malignant cells in
patients with Acute Lymphocytic Leukemia (ALL). By inhibiting the function of CD19,
Lymphocure causes the immune system to destroy malignant cells while protecting healthy
ones.
Adverse Reactions:
Lymphocure, like other medicines, has the potential to induce negative effects. The following
are the most common adverse effects documented in clinical trials:
Reactions to infusion: Lymphocure is given intravenously and can induce fever, chills,
headache, nausea, vomiting, and allergic reactions. These responses can be controlled by
slowing down or stopping the infusion and delivering appropriate therapy.
Neutropenia: Lymphocure may result in a reduction in the quantity of neutrophils, a kind of
white blood cell that aids in the fight against infections. This increases the likelihood of
bacterial infections, and patients may require antibiotics or antifungal medications to prevent
or cure infections.
Thrombocytopenia: Lymphocure may induce a drop in platelet count, which is required for
blood coagulation. This increases the risk of bleeding, and patients may require platelet
transfusions or other therapies to control their bleeding.
Anemia: Lymphocure may result in a reduction in the quantity of red blood cells, resulting in
anemia and weariness. To treat anemia, patients may require red blood cell transfusions.
Lymphocure may cause the release of cytokines, which are immune system signaling
molecules, resulting in cytokine release syndrome. Flu-like symptoms such as fever,
exhaustion, muscular pains, and low blood pressure might result from this. Severe instances
of cytokine release syndrome can be fatal and need immediate medical attention.
Tumor lysis syndrome: Lymphocure may cause cancer cells to be rapidly destroyed, releasing
huge quantities of potassium, phosphate, and other biological components into the
circulation. This can lead to electrolyte imbalances, renal damage, and other problems. To
avoid or manage tumor lysis syndrome, patients may require hydration, electrolyte
replacement, and other therapy.
It should be noted that not all patients may have these adverse effects, and the severity of side
effects might vary from patient to patient. Patients using Lymphocure should be thoroughly
watched for any evidence of adverse effects and should get any necessary supportive
treatment.
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LYMPHOCURE
Preclinical Data
Lymphocure has been shown in preclinical experiments to attach to CD19 and CD20
receptors on cancer cells and promote immune-mediated death of these cells. Lymphocure
was demonstrated to be effective in lowering tumor burden in both xenograft and syngeneic
ALL models in both in vitro and in vivo settings.
Data on safety and toxicity that is relevant
Lymphocure was usually well-tolerated in toxicity investigations in rats and nonhuman
primates at dosages up to ten times the suggested therapeutic dose. There were no reported
treatment-related fatalities or serious side effects. Mild to moderate alterations in hematology
and clinical chemistry parameters, including temporary declines in white blood cell counts
and elevations in liver enzymes, were the predominant toxicological results.
Furthermore, a repeat-dose toxicity investigation in cynomolgus monkeys revealed no
indication of Lymphocure buildup following repeated dosage, as well as no detrimental
effects on organ weights or histology. The maximum dose examined was judged to be the No
Observed Adverse Effect Level (NOAEL).
Preclinical study summary
Overall, the preclinical studies suggest that Lymphocure might be developed as a feasible
treatment option for patients with relapsed or refractory ALL. The safety and toxicology
findings imply that the planned clinical dosage is well tolerated and that the medicine has a
positive risk-benefit profile.
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LYMPHOCURE
Proposed clinical trial design, endpoints, and safety monitoring plan
A multicenter, open-label, single-arm, phase 2 research is proposed for Lymphocure in
relapsed or refractory ALL. Up to 100 adult patients with relapsed or refractory ALL who
have had at least two previous lines of treatment, including a CD19-targeted therapy and an
anthracycline-based regimen, will be enrolled in the research. Lymphocure will be
administered to patients as a single treatment at a dose of 200 mg twice day until disease
progression, unacceptable toxicity, or withdrawal of consent occurs.
Endpoints: The overall response rate (ORR) will be the primary outcome of the research,
defined as the proportion of patients who achieve a complete response (CR), full response
with incomplete blood count recovery (CRi), or partial response (PR) according to the 2017
updated IWG criteria for ALL. Duration of response (DOR), progression-free survival (PFS),
overall survival (OS), and safety will be secondary goals.
Safety Monitoring Plan: Clinical laboratory testing, physical examinations, and adverse event
(AE) reporting will be used to monitor safety throughout the trial. Patients will be evaluated
for adverse events (AEs) at each study visit and will be monitored for safety for 30 days after
stopping Lymphocure. For the management of AEs, dosage reductions and interruptions will
be permitted, and dose changes will be performed based on the severity and duration of the
AEs.
Phase II/III Studies: If the phase 2 study findings are encouraging, a critical phase 3 trial will
be undertaken to support regulatory approval of Lymphocure for the treatment of relapsed or
refractory ALL. The phase 3 trial will be a randomized, controlled trial comparing
Lymphocure plus standard of care (SOC) versus SOC alone in patients with relapsed or
refractory ALL who have previously undergone at least two lines of treatment, including a
CD19-targeted therapy and an anthracycline-based regimen. The phase 3 study's primary goal
will be progression-free survival (PFS), with secondary endpoints including overall survival
(OS), overall response rate (ORR), and safety. The trial, which is planned to last 2-3 years,
will enroll up to 300 individuals.
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LYMPHOCURE
Proposed regulatory pathway and timeline for submission
The FDA's fast approval program for the treatment of relapsed or refractory ALL is the
planned regulatory approach for Lymphocure. Based on the results of the phase 2 trial, a New
Drug Application (NDA) for Lymphocure will be submitted, followed by a confirmatory
phase 3 study to support complete approval.
The NDA is planned to be submitted about two years following the end of the phase two
research. The NDA review process is estimated to take up to 12 months, followed by eventual
FDA approval. The confirmatory phase 3 study is scheduled to begin soon after the NDA is
submitted and continue throughout the review process. The conclusion of the phase 3 trial
and eventual final approval is expected to take another 2-3 years.
Potential for Accelerated Approval:
Because of the unmet medical need for patients with relapsed or refractory ALL and the
impressive preclinical and clinical results to date, the possibility for speedy approval of
Lymphocure is strong. Lymphocure would be authorized faster if it was based on a surrogate
objective, such as overall response rate (ORR), rather than a clinical endpoint, such as
progression-free survival (PFS) or overall survival (OS). The ORR objective is predicted to
be reached in the phase 2 research, and a confirmatory phase 3 study would be necessary to
validate Lymphocure's therapeutic benefit.
Furthermore, Lymphocure may be eligible for FDA breakthrough treatment designation
and/or priority review, which would speed up the review process and perhaps lead to quicker
approval. Overall, the regulatory approach and possibility for rapid approval for Lymphocure
are encouraging, and we look forward to collaborating closely with the FDA throughout the
submission and review process.
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LYMPHOCURE
Proposed Risk Minimization Measures:
Lymphocure is a powerful and targeted therapy for relapsed or refractory ALL, and it is
critical that patients receive the necessary treatment and monitoring to reduce the potential
hazards associated with its use. The risk-mitigation measures proposed include:
Lymphocure will only be available through accredited speciality pharmacies that have been
trained to handle and dispense the medicine correctly.
Patient selection criteria: Patients must meet the study's inclusion and exclusion criteria to be
considered suitable candidates for Lymphocure treatment.
Patient monitoring: During and after treatment with Lymphocure, patients will be thoroughly
followed for any adverse events, including laboratory testing and physical exams.
Healthcare practitioners will be required to receive training on the proper use and
administration of Lymphocure, as well as the management of potential adverse events.
Risk communication: Patients and healthcare providers will be informed about the potential
hazards of Lymphocure, such as cytokine release syndrome and neurological toxicities.
Plans for Post-Marketing Pharmacovigilance:
Post-marketing pharmacovigilance is crucial for identifying and managing any potential
safety problems with Lymphocure. Post-marketing pharmacovigilance plans include:
Adverse event reporting: Healthcare practitioners and patients will be encouraged to notify
the FDA and the manufacturer of any adverse events connected with Lymphocure.
Long-term outcomes will be tracked for patients treated with Lymphocure, including disease
response, progression-free survival, and overall survival.
Risk management plan: A risk management plan will be established and implemented to
detect and address any potential safety risks linked with Lymphocure.
Regular safety reviews will be done to monitor the safety of Lymphocure and identify any
developing safety issues.
Overall, the suggested risk-mitigation procedures and post-marketing pharmacovigilance
plans for Lymphocure are intended to assure the drug's safe and effective usage in patients
with relapsed or refractory ALL.
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LYMPHOCURE
Questions for FDA
Question: Based on the preliminary evidence, we believe Lymphocure has the potential to
significantly assist patients with relapsed or refractory ALL. What extra data would the FDA
advise us to collect in our phase II trial to support the possibility of speedy approval?
Company position: We believe that the available preclinical data supports the potential for
accelerated approval of Lymphocure. We are committed to working closely with the FDA to
identify the most appropriate clinical trial endpoints and design to support this pathway.
Question: A single-arm, multicenter phase II research is included in our suggested clinical
trial design. Can you give me your thoughts on the trial design and sample size required to
demonstrate efficacy and safety in this patient population?
Company position: A single-arm, multicenter phase II research, we feel, is a reasonable
design for assessing the effectiveness and safety of Lymphocure in patients with relapsed or
refractory ALL. The trial was planned with key opinion leaders' input, and we believe it will
give significant evidence to support the development of this essential therapeutic option.
Question: We are thinking about making overall survival the primary objective of our phase
III trial. Can you offer advice on using overall survival as a primary outcome in trials with
relapsed or refractory ALL?
Company position: We believe that overall survival is an adequate primary objective for our
phase III research. We recognize the difficulties in showing a survival benefit in this patient
population and are dedicated to conducting a comprehensive trial to assess the potential
benefit of Lymphocure in these individuals. We look forward to addressing the use of overall
survival as a main endpoint with the FDA, as well as investigating other alternative endpoints
that may be appropriate.
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LYMPHOCURE
List of specific questions and topics for discussion
Can you provide guidance on the proposed clinical trial design and endpoints for
Lymphocure? Are there any additional endpoints that should be considered for the trial?
How do you recommend balancing the potential risks and benefits of Lymphocure in patients
with relapsed or refractory ALL?
What is the likelihood of accelerated approval for Lymphocure based on the available
preclinical and clinical data?
What is the FDA’s position on the proposed risk minimization measures for Lymphocure,
including the restricted distribution, patient monitoring, and healthcare provider training
requirements?
Can you provide guidance on the plans for post-marketing pharmacovigilance for
Lymphocure? Are there any additional safety monitoring measures that should be considered?
Are there any potential drug interactions or contraindications that should be considered with
Lymphocure?
How do you recommend addressing the potential for cytokine release syndrome and
neurological toxicities associated with Lymphocure?
What is the FDA’s position on the proposed target product profile for Lymphocure, including
the proposed patient population and treatment goals?
Are there any additional studies or data that should be considered for Lymphocure prior to
submission for FDA approval?
What is the FDA’s timeline for review and approval of Lymphocure, and are there any
potential challenges or obstacles that should be anticipated?
Supporting documentation, including relevant scientific literature, regulatory guidance
documents, and clinical trial protocols.
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LYMPHOCURE
Here are some regulatory guidance documents and clinical trial procedures that may be useful
in the development of the aforementioned drug:
FDA Industry Guidance: Drugs and biologics: Expedited Programs for Serious Conditions:
This guidance document discusses the expedited programs available for the development and
licensing of medicines and biologics for critical or life-threatening illnesses such as acute
lymphocytic leukemia.
FDA Guidance for Industry: Developing Products for Treatment of Hematological Disorders
Using Animal Models: This paper contains suggestions on the use of animal models in the
development of medications for hematological disorders like leukemia.
FDA Guidance for Industry: Clinical Trial Endpoints for Cancer Drug and Biologic Approval:
This document contains information on the clinical trial endpoints that are acceptable for
cancer drug and biologic approval, including those for acute lymphocytic leukemia.
ClinicalTrials.gov This website includes thorough information on the required data items for
clinical trial protocols, particularly those for interventional trials utilizing experimental
medications.
Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from the National Cancer
Institute: This website offers a standardized system for classifying the severity of adverse
events in clinical trials, which can aid in the consistency of reporting and monitoring of safety
data.
International Clinical Trials Registry Platform (ICTRP) of the World Health Organization:
This resource offers a searchable database of clinical trial protocols and outcomes from
across the world, which can aid in the design and execution of clinical studies for the
aforementioned medicine.
These resources should be used in conjunction with the specific regulatory requirements and
guidelines for the development of medications for acute lymphocytic leukemia. It is advised
that regulatory specialists and/or FDA representatives be consulted for particular guidance on
the development and approval of the aforementioned medicine.
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LYMPHOCURE
References:
1. Pediatric drug development
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pediatric-drug-
development-under-pediatric-research-equity-act-and-best-pharmaceuticals-children-act
2. Patient-Focused Drug Development
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-
focused-drug-development-incorporating-clinical-outcome-assessments-endpoints-regulatory
3. Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-
considerations-support-accelerated-approval-oncology-therapeutics
2. BESPONSA (inotuzumab ozogamicin) FDA Approval package
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761040Orig1s000TOC.cfm
6. BESPONSA (inotuzumab ozogamicin) Administrative documents
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761040Orig1s000AdminCorres.p
df
7. BESPONSA (inotuzumab ozogamicin) Multidisciplinary document
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761040Orig1s000Multidiscipline
R.pdf
8. BESPONSA (inotuzumab ozogamicin) Risk evaluation document
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761040Orig1s000RiskR.pdf
9. BESPONSA (inotuzumab ozogamicin) Chemistry review document
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761040Orig1s000ChemR.pdf
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