New Indications for Keytruda
May 18, 2017 – The U.S. FDA has approved Merck’s Keytruda® (pembrolizumab) for a new indication as a first-line treatment for metastatic nonsquamous non-small cell lung cancer (NSCLC), whether or not the cancer expresses PD-L1. Keytruda will be used in combination therapy with Alimta® (pemetrexed – Eli Lilly) and carboplatin. Full approval has not yet been granted, and will depend on positive results from additional trials.
Keytruda also received accelerated approval to treat locally advanced or metastatic urothelial carcinoma (bladder, ureter and/or urethra cancer) in patients who are not eligible for cisplatin-containing chemotherapy. Accelerated approval is granted for drugs with clinical study information showing promise for treating serious or life-threatening diseases, even though studies are not completed.
Standard approval has been granted for Keytruda as a treatment for patients with locally advanced or metastatic urothelial carcinoma who have progressed on or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, boosts the immune system’s ability to attack cancer cells. Keytruda's label now includes indications in melanoma, non-small cell lung cancer (NSCLC), squamous cell cancer of the head and neck (SCCHN), classical Hodgkin's lymphoma and urothelial carcinoma.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.