The Food and Drug Administration's calendar for making decisions on new cancer 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.
The Food and Drug Administration’s calendar for making decisions on new cancer 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 FDA has been approving many oncology drugs ahead of the goal dates. These key dates have been announced:
Multiple Myeloma: The FDA is expected to decide on a new indication for Revlimid (lenalidomide) plus dexamethasone in newly diagnosed patients with multiple myeloma who are not candidates for stem cell transplant, according to Celgene.
Breast Cancer: Ibrance (palbociclib), 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.
Thyroid Cancer: Lenvatinib, an oral multiple receptor tyrosine kinase inhibitor, is under consideration as a treatment for progressive radioiodine-refractory differentiated thyroid cancer, according to Eisai.
Waldenström macroglobulinemia: Imbruvica (ibrutinib) is under review as a treatment for patients with Waldenström macroglobulinemia, according to Pharmacyclics, which is developing the drug along with Janssen Biotech. It is currently approved for patients with chronic lymphocytic leukemia and mantle cell lymphoma. If approved, Imbruvica will be the first treatment specifically approved for the rare disease.
Melanoma: Talimogene laherparepvec, or simply T-VEC, is an oncolytic immunotherapy under review for the treatment of metastatic melanoma based on clinical trial data evaluating patients with stage 3B-4 melanoma that are not surgically resectable, according to Amgen.
These applications are also pending, with no specific decision dates announced thus far:
Basal Cell Carcinoma: Sonidegib (LDE225) An application has been submitted as a treatment for patients with advanced basal cell carcinoma, Novartis has reported.
Colorectal Cancer: TAS-102—A new drug application was 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.
Lung Cancer: Iressa (gefitinib)—The oral tyrosine kinase inhibitor could be approved as a monotherapy for treatment of newly diagnosed patients with advanced or metastatic EGFR-mutated non-small cell lung cancer. Iressa initially gained accelerated in the United States in 2003 but was withdrawn from the market two years later after faltering in confirmatory clinical trials.
Melanoma: Cobimetinib (GDC-0973)—An application has been submitted for the use of this novel MEK inhibitor in combination with Zelboraf (vemurafenib), a BRAF inhibitor, for patients with advanced melanoma that contains a BRAF V600 mutation, according to Genentech.
Multiple Myeloma: Panobinostat (LBH589)—The pan-deacetylase inhibitor remains under review in combination with Velcade (bortezomib) and dexamethasone as a therapy for patients with previously treated multiple myeloma, according to Novartis.
Multiple Myeloma: Captisol-enabled melphalan—This novel formulation of the long-standing anticancer agent melphalan 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.
Sarcoma: Yondelis (trabectedin)—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.