The FDA’s calendar for making decisions on new oncology drugs and indications is taking shape for 2015, and the clock is ticking on at least 13 applications for novel agents and new therapeutic settings for existing drugs.
Although more than 750 oncology medicines and vaccines are in development according to the Pharmaceutical Research and Manufacturers of America, only a fraction of those drugs will make it to the FDA for a final ruling in any particular year.
Here is a snapshot of therapies where applications have been completed and are under review, culled from company announcements about their research. The FDA does not disclose information about pending applications.
In some case, companies have identified deadlines by which the FDA has agreed to make a decision on whether to approve the drug, although the agency has been approving many oncology drugs ahead pf the goal dates. These key dates have been announced:
- February 22—The agency is expected to decide on a new indication for lenalidomide (Revlimid) plus dexamethasone in newly diagnosed patients with multiple myeloma who are not candidates for stem cell transplant, according to Celgene.
- March 8—A new drug application is pending for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), a fungal infection predominantly occurring in immunocompromised patients, according to Astellas.
- April 13—Palbociclib (Ibrance), an novel oral agent that targets CDK4/6, is under review as a first-line treatment in combination with letrozole for postmenopausal women with estrogen receptor—positive, HER2-negative advanced breast cancer who have not received previous systemic treatment for advanced disease, according to Pfizer. (The company said it has entered label discussions with the FDA for the drug).
- April 14—Lenvatinib mesylate, an oral multiple receptor tyrosine kinase inhibitor, is under consideration as a treatment for progressive radioiodine-refractory differentiated thyroid cancer, according to Eisai.
- April 17—Ibrutinib (Imbruvica), a Bruton tyrosine kinase inhibitor, is under review as a treatment for patients with Waldenström macroglobulinemia, according to Pharmacyclics, which is developing the drug along with Janssen Biotech.
- July 28— Talimogene laherparepvec (TVEC), an oncolytic immunotherapy, is under review for the treatment of regionally or distantly metastatic melanoma based on clinical trial data evaluating TVEC in patients with stage IIIB-IV melanoma that are not surgically resectable, according to Amgen.
These applications also are pending, with no specific decision dates announced thus far:
- Captisol-enabled melphalan—This novel propylene glycol—free formulation of the longstanding anticancer agent is under consideration for two multiple myeloma indications: as a high-dose conditioning regimen prior to stem cell transplant and as a palliative treatment when oral therapy is not appropriate.
- Cobimetinib (GDC-0973)—An application has been submitted for the use of this novel MEK inhibitor in combination with vemurafenib (Zelboraf), a BRAF inhibitor, for patients with advanced melanoma that tests positive for a BRAF V600 mutation, according to Genentech.
- Gefitinib (Iressa)—AstraZeneca is seeking approval for the oral tyrosine kinase inhibitor as monotherapy for the first-line treatment of patients with advanced or metastatic EGFR-mutated non—small cell lung cancer. Gefitinib initially gained accelerated in the United States in 2003 but was withdrawn from the market two years later after faltering in confirmatory clinical trials.
- Panobinostat (LBH589)—The pan-deacetylase inhibitor remains under review in combination with bortezomib and dexamethasone as a therapy for patients with previously treated multiple myeloma, according to Novartis.
- Sonidegib (LDE225) An application for this selective smoothened inhibitor has been submitted to the FDA as a treatment for patients with advanced basal cell carcinoma, Novartis has reported.
- TAS-102—A new drug application has been submitted for this nucleoside analog, which is a combination of trifluridine and tipiracil hydrochloride for the treatment of refractory metastatic colorectal cancer, Taiho Oncology has announced.
- Trabectedin (Yondelis)—This novel agent, which interferes with the repair mechanism of aberrant DNA, is under review as a treatment for patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline, according to Janssen.