As I Said Over A Year Ago -- The Lead In This $16 Billion (2017) Market Belongs To. . . BMS's Opdivo®

Only a few days after granting it a priority review, FDA cleared nivolumab (branded as Opdivo^®) for use in metastatic lung cancers. Just as I guessed back in February of 2014, the BMS trial data was in fact so robust, BMS was able to pivot quickly toward approval -- and the FDA was comfortable approving this life saving biologic essentially. . . immediately.

And, even though it clearly gives BMS first mover advantages in a very high burden of disease sector in the US, Merck does get the back-handed benefit that this is a ringing endorsement of the anti-PD-1 approach. So, when Merck does submit (likely closer to June 2015) a biologic license application for NSCLC to FDA, it too might see a pretty rapid FDA approval. The $16 billion to $35 billion a year juggernaut begins. From the FDA overnight, then:

. . . .The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. . . .

Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. The most common type of lung cancer, NSCLC affects seven out of eight lung cancer patients, occurring when cancer forms in the cells of the lung.

Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Opdivo is intended for patients who have previously been treated with platinum-based chemotherapy.

“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”

Opdivo’s efficacy to treat squamous NSCLC was established in a randomized trial of 272 participants, of whom 135 received Opdivo and 137 received docetaxel. The trial was designed to measure the amount of time participants lived after starting treatment (overall survival). On average, participants who received Opdivo lived 3.2 months longer than those participants who received docetaxel. . . .

My guess is that Kenilworth is likely about nine to twelve months behind BMS in lung cancer. Onward.