7 in 2011: A Short List of Drugs to Watch

Published: Friday, Feb 04, 2011
From tiny biotech firms to giant pharmaceutical companies, the oncology drug development pipeline is pulsing with activity. There are nearly 900 potential new medicines and vaccines to treat cancer under study in the United States, according to the Pharmaceutical Research and Manufacturers Association of America. These include 122 for lung cancer, 107 for breast cancer, 70 for colorectal cancer, and 103 for prostate cancer. Considering the complexity of the clinical trials process, predications about which drugs will gain the FDA’s approval can stymie even the best industry analysts. Here, then, is a look at 7 oncology drugs that you’ll hear about this year, with no predictions about how they will fare in the regulatory process.

  1. 1 New Date for Vandetanib The FDA is continuing its review of vandetanib (Zictifa), a tyrosine kinase inhibitor intended for the treatment of patients with unresectable locally advanced or metastatic medullary thyroid cancer. AstraZeneca said the agency extended its decision date from January 7 to April 7 in order to review a proposed risk evaluation and mitigation strategy the company was required to submit as part of the process.
  2. Ipilimumab Decision Anticipated The FDA’s impending decision on Bristol-Myers Squibb’s promising new melanoma drug ipilimumab (Yervoy) remains a matter of great anticipation in clinical and industry circles. The agency had postponed a decision on the drug until March 26 in order to review additional information it had requested, the company announced in November. The FDA’s Oncologic Drugs Advisory Committee was scheduled to consider the drug at a February 9 meeting, but the meeting was canceled because the agency said it had resolved the scientific issues the panel was supposed to consider.
  3. More Indications Sought for Fusilev A ready-to-use formulation of Fusilev (levoleucovorin) for injection would be available to treat patients with advanced metastatic colorectal cancer if the FDA approves a supplemental new drug application submitted earlier this month. Spectrum Pharmaceuticals anticipates agency action by April 29. Fusilev, now available as freeze-dried powder, is approved as rescue therapy for osteosarcoma patients who have been treated with high doses of methotrexate and to diminish the toxicity of methotrexate. The new formulation does not have to be reconstituted and is of higher strength than the currently approved version, a company official said in a press release.
  4. Avastin Battle Not Over Yet Genentech Inc is asking the FDA for a hearing on the agency’s plans to disallow the metastatic breast cancer indication on the label for Avastin (bevacizumab). The company, a member of the Roche Group, said patients have been relying 8 / 01.11 upon the drug for 2 years, and that the European Medicines Agency reached a different conclusion than the FDA after examining the same data. Genentech filed a detailed response on January 18. In December, the FDA said the breast cancer indication should be removed because studies showed the overall survival and disease progression benefits do not outweigh serious adverse effects. The label indication for metastic HER2-negative breast cancer remains in place during the appeal. Avastin gained accelerated approval as a breast cancer treatment in 2008. Since 2004, Avastin has been approved for patients with colorectal cancer, non- small cell lung cancer, glioblastoma, and renal cell carcinoma.
  5. Iniparib Staying on Fast Track Sanofi-aventis intends to file regulatory submissions within the next several months for iniparib (BSI- 201), a PARP inhibitor that has been on the FDA’s fast track as a treatment for women with metastatic triple-negative breast cancer (mTNBC). The company reported final phase II data earlier this month, saying submissions are planned in the United States during the first quarter and with the European Union later this year. The drug is in phase III trials for mTNBC and squamous non-small cell lung cancer, and phase II trials for ovarian, uterine, and brain cancers. Sanofi-aventis research center in Strasbourg, France.
  6. Lymphoma Drug Application in the Works Key findings from a phase II clinical trial of brentuximab vedotin (SGN-35) for patients with relapsed or refractory systemic anaplastic large cell lymphoma generated excitement in research circles in December. Seattle Genetics, Inc said it plans to submit a biologics license application to the FDA during the first quarter this year. Millennium: The Takeda Oncology Company, which is developing the drug in a collaboration with Seattle Genetics, has started similar discussions with the European Medicines Agency.
  7. Progress Reported on Blood Cancer Drug The oral drug INCB18424 demonstrated positive results in a pivotal phase III clinical trial for the treatment of myelofibrosis, a blood cancer that compromises bone marrow, the Incyte Corporation said earlier this month. The company said plans are in the works to submit a new drug application to the FDA by July. The drug, which works by inhibiting JAK enzymes, is being developed under a special protocol assessment designed to expedite the approval process.

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