Keytruda (Pembrolizumab) The PD-1 immunotherapy drug – New Cancer Drug Is So Effective Against Tumors, the FDA Approved It Immediately
Pembrolizumab is known as a PD-1 blocker, an emerging type of immunotherapy drug that helps the immune system find cancer cells and attack tumors. According to the New York Times, this is the first time a drug has been approved for use against tumors that share a particular genetic profile, regardless of where they appear in the body.
On May 18, 2017, the U.S. Food and Drug Administration granted regular approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
FDA also granted accelerated approval to pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
The study was small, and there was no control group (i.e., a group that didn’t receive pembrolizumab that scientists could compare results against), but the results were so striking that the FDA has already approved pembrolizumab for patients whose cancer comes from this particular genetic abnormality.
Dr. Jack Jacoub, a medical oncologist and director of thoracic oncology at MemorialCare Cancer Institute at Orange Coast Memorial Medical Center in Fountain Valley, Calif., tells Yahoo Beauty that the study was “interesting, welcomed, and exciting.”
There has been a general opinion that the immune system is integral in the development and spread of cancer, he points out, and these new findings show that targeting the immune system to treat cancer can be effective.
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Full prescribing information for pembrolizumab is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s017s018lbl.pdf
FDA granted pembrolizumab priority review status for these indications. Prior to the submission, pembrolizumab received Breakthrough Therapy Designation for the second-line indication. An additional trial is required to confirm clinical benefit of pembrolizumab for the first-line indication. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).