November Yields Record Number of FDA Approvals for New Oncology Drugs and Drug Indications


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Richard Pazdur, MD

While the past 2 years have seen an unprecedented accelerated pace in the number of new oncology drugs entering the market, the years ahead look even more promising for new treatment options.

In 2014, the U.S. Food and Drug Administration (FDA) approved 9 new drugs and biologics in the treatment of cancer and added 10 notable new indications or formulations to existing drug labels, marking a year of significant progress in improving the quality of cancer care in the United States. So far this year, the FDA has already surpassed that number, with 13 new drug approvals—6 in November alone—plus 13 new drug indications or formulations and 1 expanded indication for lenalidomide (Revlimid) in combination with dexamethasone for newly diagnosed patients with multiple myeloma.1

Among the list of anticancer therapies approved this year are a number of FDA-approval firsts, including ixazomib ­(Ninlaro), the first approved oral proteasome inhibitor in the treatment of multiple myeloma; panobinostat (Farydak), the first-ever histone deacetylase inhibitor to receive FDA approval, also for multiple myeloma; and palbociclib (Ibrance), the first drug in a new class of cyclin-dependent kinase (CDK) 4 and CDK 6 selective inhibitors, in the treatment of metastatic breast cancer.

Among the new drug indications approved by the FDA so far this year are pembrolizumab ­(Keytruda) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express ­programmed cell death ligand 1 (PD-L1) and ibrutinib (Imbruvica) in the treatment of Waldenström’s macroglobulinemia. Originally approved in 2014 for patients with metastatic melanoma, pembrolizumab is the first anti–PD-L1 therapy approved for both squamous and nonsquamous metastatic NSCLC. Ibrutinib, a kinase inhibitor, was originally approved in 2013 for the treatment of patients with mantle cell lymphoma, and last year it received an FDA Breakthrough Therapy designation in the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL), advancing clinical care for high-risk patients with CLL.

Another milestone in new oncology treatments in 2015 is filgrastim-sndz (Zarxio), the first FDA-approved biosimilar product in the United States. Filgrastim-sndz is biosimilar to filgrastim (Neupogen) and helps prevent infections in patients receiving chemotherapy.

Drugs in the Pipeline

While the past 2 years have seen an unprecedented accelerated pace in the number of new oncology drugs entering the market, the years ahead look even more promising for new treatment options. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), there are 771 new cancer drugs and vaccines in development, 80% of which are potentially first in class, representing approaches to treating cancer that are different from any other marketed therapy.2 They include nearly 100 new drugs for the treatment of lung cancer, 87 for leukemia, 78 for lymphoma, and 73 for breast cancer, among others.

The scientific advancements in oncology drugs, along with technologic and oncology practice innovations, have resulted in marked improvements in cancer survival rates and 14.5 million Americans now living with a history of cancer.3 And despite the ongoing challenge of how to meet the increasing costs of cancer therapies, novel drug discoveries are likely to continue to fuel innovation in cancer care, improving outcomes for patients. ■

Disclaimer: The number of new drug indications or formulations included in the FDA approvals update cited in reference 1 may not be the complete number for 2015.

References

1. U. S. Food and Drug Administration: Hematology/oncology (cancer) approvals & safety notifications. Available at www.fda.gov/drugs/informationondrugs/approveddrugs/ucm279174.htm. Accessed December 1, 2015.

2. Pharmaceutical Research and Manufacturers of America: Nearly 800 medicines and vaccines in clinical testing for cancer offer new hope to patients: 2014 Report. Available at phrma.org/sites/default/files/pdf/2014-cancer-report.pdf. Accessed December 1, 2015.

3. American Cancer Society: Cancer Treatment & Survivorship Facts & Figures: 2014-2015. Available at cancer.org/acs/groups/content/@research/documents/document/acspc-042801.pdf. Accessed December 1, 2015.



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