Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker

A tray containing cancer cells sits on an optical microscope in the Nanomedicine Lab at UCL's School of Pharmacy
A tray containing cancer cells sits on an optical microscope in the Nanomedicine Lab at UCL's School of Pharmacy
Author

25 May, 2017

The FDA just released its approval for a cancer treatment that uses a genetic biomarker, rather than bases its use on where the cancer started, a first for the agency.

The approval further solidifies Merck's leading position in the burgeoning field of treatments that help the immune system fight cancer, a mantle it seized previous year when Keytruda extended survival as an initial treatment for advanced non-small cell lung cancer (NSCLC).

Merck shares rose about 1 percent to $64.65.

Next month, Merck will present the findings of 50 studies testing pembrolizumab's use on 16 different cancers at the 53rd Annual Meeting of the American Society of Clinical Oncology.

The FDA has approved a new indication for pembrolizumab (Keytruda, Merck), an anti-programmed death 1 (PD-1) receptor therapy. Instead, the FDA acted very quickly to branch out from urothelial cancer to mesothelioma and, one week later, all cancers with the same biomarker.

IHC identified dMMR cancer in 47 patients, MSI-H was identified by PCR in 60 patients, and 42 patients were identified with both tests.

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Who has the FDA Approved for Pembrolizumab Usage?

The new pembrolizumab approval covers adult and pediatric patients with any type of tumor that exhibits microsatellite instability-high (MSI-H) or mismatch fix deficiency (dMMR).

Doctors can now prescribe Keytruda (ingredient: pembrolizumab) to patients with a particular cancer biomarker, a substance or process indicative of the presence of cancer, which is a milestone for the development of precision medicine that takes an individual's variability in environment, lifestyle and genes into account.

As with most new medications, Merck & Co. can not say with complete certainty exactly how and why pembrolizumab works.

Pembrolizumab disrupts the PD-1/PD-L1 immune checkpoint pathway that modulates the human immune system's natural anticancer activity.

Beyond CRC, other tumor types in which patients had responses included endometrial cancer (n = 5), biliary cancer (n = 3), gastric or GE junction cancer (n = 5), pancreatic cancer (n = 5), small intestinal cancer (n = 3), breast cancer (n = 2), prostate cancer (n = 1), esophageal cancer (n = 1), retroperitoneal adenocarcinoma (n = 1), and small cell lung cancer (n = 1). Eli Lilly and Co (LLY) and Allergan plc (AGN) have significant upside potential because of products they are developing which could help address health problems like cancer and macular degeneration, according to a special feature in Barron's. It also includes patients with colorectal cancer whose disease has advanced after chemotherapy. It now seems feasible that future efforts will mostly be targeted toward defeating specific biomarkers instead of aiming to assist just one type of cancer.


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