Martin H Cohen

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. pmc Approval summary: Cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil for the first-line treatment of patients with recurrent locoregional or metastatic squamous cell head and neck cancer
    Martin H Cohen
    Office of Hematology Oncology Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 18:460-6. 2013
  2. pmc Approval summary: imatinib mesylate for one or three years in the adjuvant treatment of gastrointestinal stromal tumors
    Martin H Cohen
    U S Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Oncologist 17:992-7. 2012
  3. ncbi request reprint FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL)
    Patricia Anne Dinndorf
    U S Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 2102, Silver Spring, Maryland 20993 0002, USA
    Oncologist 12:991-8. 2007
  4. ncbi request reprint FDA drug approval summary: bevacizumab (Avastin) plus Carboplatin and Paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 12:713-8. 2007
  5. ncbi request reprint Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors
    Martin H Cohen
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Oncologist 14:174-80. 2009
  6. ncbi request reprint Approval summary: nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma
    Martin H Cohen
    Division of Drug Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Cancer Res 12:5329-35. 2006
  7. doi request reprint Approval summary: pemetrexed in the initial treatment of advanced/metastatic non-small cell lung cancer
    Martin H Cohen
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, White Oak Campus, Silver Spring, Maryland 20993 0002, USA
    Oncologist 14:930-5. 2009
  8. ncbi request reprint FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 14:1131-8. 2009
  9. doi request reprint FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia/lymphoma
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA
    Oncologist 13:709-14. 2008
  10. pmc Approval summary: imatinib mesylate in the adjuvant treatment of malignant gastrointestinal stromal tumors
    Martin H Cohen
    U S Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 2102, Silver Spring, Maryland 20993 0002, USA
    Oncologist 15:300-7. 2010

Collaborators

Detail Information

Publications34

  1. pmc Approval summary: Cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil for the first-line treatment of patients with recurrent locoregional or metastatic squamous cell head and neck cancer
    Martin H Cohen
    Office of Hematology Oncology Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 18:460-6. 2013
    ..Conjunctivitis occurred in 10% of cetuximab patients. Other adverse reactions, sometimes severe, included infusion reactions, hypomagnesemia, hypocalcemia, and hypokalemia...
  2. pmc Approval summary: imatinib mesylate for one or three years in the adjuvant treatment of gastrointestinal stromal tumors
    Martin H Cohen
    U S Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Oncologist 17:992-7. 2012
    ..The most common adverse reactions, as noted in previous imatinib studies, were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting, and abdominal pain...
  3. ncbi request reprint FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL)
    Patricia Anne Dinndorf
    U S Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 2102, Silver Spring, Maryland 20993 0002, USA
    Oncologist 12:991-8. 2007
    ..Disclosure of potential conflicts of interest is found at the end of this article...
  4. ncbi request reprint FDA drug approval summary: bevacizumab (Avastin) plus Carboplatin and Paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 12:713-8. 2007
    ....
  5. ncbi request reprint Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors
    Martin H Cohen
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Oncologist 14:174-80. 2009
    ..The most common laboratory abnormality was anemia. Most often the AEs were of mild-to-moderate severity. Fluid retention events and skin rash were numerically reported more often in the 800-mg/day treatment cohort of patients...
  6. ncbi request reprint Approval summary: nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma
    Martin H Cohen
    Division of Drug Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Cancer Res 12:5329-35. 2006
    ....
  7. doi request reprint Approval summary: pemetrexed in the initial treatment of advanced/metastatic non-small cell lung cancer
    Martin H Cohen
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, White Oak Campus, Silver Spring, Maryland 20993 0002, USA
    Oncologist 14:930-5. 2009
    ..No new pemetrexed safety signals were observed...
  8. ncbi request reprint FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 14:1131-8. 2009
    ..g., CNS hemorrhage, wound-healing complications, and thromboembolic events) to either bevacizumab, underlying disease, or both could not be determined because of the single-arm, noncomparative study design...
  9. doi request reprint FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia/lymphoma
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA
    Oncologist 13:709-14. 2008
    ....
  10. pmc Approval summary: imatinib mesylate in the adjuvant treatment of malignant gastrointestinal stromal tumors
    Martin H Cohen
    U S Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 2102, Silver Spring, Maryland 20993 0002, USA
    Oncologist 15:300-7. 2010
    ..Drug was discontinued for adverse reactions in 17% and 3% of the imatinib and placebo-treated patients, respectively...
  11. pmc Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approval
    Martin H Cohen
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 16:1762-70. 2011
    ..Lipid-lowering medications were required for 25% of patients on letrozole and 16% of patients on tamoxifen...
  12. pmc Approval summary: pemetrexed maintenance therapy of advanced/metastatic nonsquamous, non-small cell lung cancer (NSCLC)
    Martin H Cohen
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 15:1352-8. 2010
    ..The most common (>5%) adverse reactions in patients receiving pemetrexed were hematologic toxicity, an increase in hepatic enzymes, fatigue, gastrointestinal toxicity, sensory neuropathy, and skin rash...
  13. pmc Approval summary: erlotinib maintenance therapy of advanced/metastatic non-small cell lung cancer (NSCLC)
    Martin H Cohen
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 15:1344-51. 2010
    ..In total, 59% of placebo-treated patients who received treatment received FDA approved second-line NSCLC drugs. The most common adverse reactions in patients receiving erlotinib were rash and diarrhea...
  14. ncbi request reprint FDA drug approval summary: erlotinib (Tarceva) tablets
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, Maryland 20857, USA
    Oncologist 10:461-6. 2005
    ..In the first-line treatment of NSCLC, two large, controlled, randomized trials showed no benefit from adding erlotinib to doublet, platinum-based chemotherapy. Therefore, erlotinib is not indicated for use in this setting...
  15. ncbi request reprint FDA drug approval summary: lapatinib in combination with capecitabine for previously treated metastatic breast cancer that overexpresses HER-2
    Qin Ryan
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Oncologist 13:1114-9. 2008
    ..There was a 2% incidence of reversible decreased left ventricular function in the combination arm...
  16. ncbi request reprint FDA drug approval summary: bevacizumab plus FOLFOX4 as second-line treatment of colorectal cancer
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, Maryland 20857, USA
    Oncologist 12:356-61. 2007
    ....
  17. doi request reprint FDA review of a panitumumab (Vectibix) clinical trial for first-line treatment of metastatic colorectal cancer
    Ruthann M Giusti
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
    Oncologist 14:284-90. 2009
    ..The use of panitumumab in this setting cannot be recommended...
  18. ncbi request reprint United States Food and Drug Administration Drug Approval summary: Gefitinib (ZD1839; Iressa) tablets
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 10:1212-8. 2004
    ..Accelerated approval regulations require the sponsor to conduct additional studies to verify that gefitinib therapy produces such benefit...
  19. ncbi request reprint FDA drug approval summary: gefitinib (ZD1839) (Iressa) tablets
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 8:303-6. 2003
    ..Accelerated approval regulations require the sponsor to conduct further studies to verify that gefitinib therapy produces such a benefit...
  20. ncbi request reprint FDA approval summary: vorinostat for treatment of advanced primary cutaneous T-cell lymphoma
    Bhupinder S Mann
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland, USA
    Oncologist 12:1247-52. 2007
    ..Grade 3 or greater chemistry abnormalities included hyperglycemia, hypertriglyceridemia, and hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, hyperkalemia, hypercholesterolemia, hypophosphatemia, and increased creatinine...
  21. ncbi request reprint Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 11:6767-71. 2005
    ..1 months (radiotherapy alone). Adverse events during temozolomide treatment included thrombocytopenia, nausea, vomiting, anorexia, constipation, alopecia, headache, fatigue, and convulsions...
  22. ncbi request reprint FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 10:363-8. 2005
    ..Of greatest importance, pemetrexed caused significantly less neutropenia, febrile neutropenia, neutropenic infections, and need for granulocyte/macrophage colony-stimulating factors...
  23. ncbi request reprint U.S. Food and Drug Administration drug approval summaries: imatinib mesylate, mesna tablets, and zoledronic acid
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 7:393-400. 2002
    ..Information provided includes rationale for drug development, study design, efficacy and safety results, and pertinent literature references...
  24. ncbi request reprint Approval summary: letrozole in the treatment of postmenopausal women with advanced breast cancer
    Martin H Cohen
    Division of Oncology Drug Products HFD 150, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 8:665-9. 2002
    ..The manufacturer made a commitment to provide updated information on survival...
  25. ncbi request reprint FDA drug approval summary: panitumumab (Vectibix)
    Ruthann M Giusti
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Oncologist 12:577-83. 2007
    ..The most serious adverse events were pulmonary fibrosis, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, diarrhea, and constipation...
  26. ncbi request reprint FDA drug approval summaries: oxaliplatin
    Amna Ibrahim
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 9:8-12. 2004
    ..Approval was based on response rate and on an interim analysis of TTP. No results are available, at this time, that demonstrate a clinical benefit, such as improvement in disease-related symptoms or survival...
  27. ncbi request reprint Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia
    Martin H Cohen
    Division Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 8:935-42. 2002
    ..In this report, we describe the preclinical profile of imatinib and the data submitted in the New Drug Application that led to its marketing approval...
  28. pmc FDA drug approval summary: bevacizumab plus interferon for advanced renal cell carcinoma
    Jeff Summers
    U S Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 2113, Silver Spring, Maryland 20993 0002, USA
    Oncologist 15:104-11. 2010
    ..The most common bevacizumab-related toxicities were bleeding/hemorrhage, hypertension, proteinuria, and venous or arterial thromboembolic events...
  29. pmc U.S. Food and Drug Administration Approval: peginterferon-alfa-2b for the adjuvant treatment of patients with melanoma
    Thomas M Herndon
    Division of Biological Oncology Products, Food and Drug Administration, 10903 New Hampshire Avenue, Building 22, Room 5222, Silver Spring, Maryland 20993, USA
    Oncologist 17:1323-8. 2012
    ..Five deaths were reported within 30 days of the last treatment dose, two resulting from cardiovascular disease considered as possibly related to treatment...
  30. ncbi request reprint FDA drug approval summaries: fulvestrant
    Peter F Bross
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, MD 20857, USA
    Oncologist 7:477-80. 2002
    ..Approval was based on similarity of response rates and time to progression between fulvestrant and anastrozole...
  31. ncbi request reprint U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 11:12-9. 2005
    ..The present review, based on a safety and efficacy report submitted on December 20, 2002, summarizes data applicable to the conversion of these three CML indications to full approval status...
  32. ncbi request reprint Gleevec for the treatment of chronic myelogenous leukemia: US. Food and Drug Administration regulatory mechanisms, accelerated approval, and orphan drug status
    Martin H Cohen
    Division of Oncology Drug Products HFD 150, Center for Drug Evaluation and Research and Office of Orphan Products Development, Office of the Commissioner, Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 7:390-2. 2002
    ..The purpose of this report is to summarize FDA regulatory mechanisms, i.e., accelerated approval and orphan drug regulations, that have permitted patients to receive this drug as rapidly as possible...
  33. doi request reprint FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease
    Min Lu
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 10903, USA
    Am J Hematol 85:315-9. 2010
    ..9%, including three patients with serious hypotensive reactions. Ferumoxytol administration may transiently affect the diagnostic ability of magnetic resonance imaging and the drug label provides further information regarding this effect...
  34. doi request reprint FDA report: eculizumab (Soliris) for the treatment of patients with paroxysmal nocturnal hemoglobinuria
    Andrew Dmytrijuk
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Oncologist 13:993-1000. 2008
    ..Patients must be monitored and evaluated immediately for early signs of meningococcal infections and treated with antibiotics as indicated...