FDA quickly greenlights expanded use of Bristol Myers cancer therapy

March 7, 2022

Last Friday, four months ahead of schedule, Bristol Myers Squibb’s Opdivo won an ultra-fast FDA expanded use approval as the first pre-surgery therapy for early-stage non-small cell lung cancer (NSCLC).

First approved in 2014, the cancer drug along with chemotherapy is now approved for use in patients with early-stage non-small cell lung cancer, an aggressive form of lung cancer, prior to tumor extraction surgery. The drug’s expanded approval reflects a broader sense of urgency to move PD-(L)1 drugs into earlier lines of therapy, a race that could change standard treatments for cancer as we know them.

In the phase III trial that led to the OK, 388 patients with operable lung cancer were divided into groups who either received chemotherapy alone or chemotherapy plus Opdivo before surgery. Those in the Opdivo cohort went a median of 31.6 months without any type of recurrence, compared to 20.8 months for patients on chemo alone.

The nod marks a big win for Bristol Myers, who despite introducing the first PD-(L)1 drug to the market, has recently fallen behind Merck's Keytruda in the NSCLC space. Inspired by the win, other pharma companies are now running trials in the same setting, Roche and Merck included.

The win also redeems a few turbulent trials that Bristol Myers put an end to a few years ago. Some included the testing of Opdivo's effect on brain and liver cancer.