Dive Brief:

• The Food and Drug Administration on Wednesday approved Bristol Myers Squibb’s new lung cancer medication Augtyro, which the drugmaker believes will be able to outperform rivals from Pfizer and Roche based on how well it keeps disease in check.

• Known scientifically as repotrectinib, Augtyro is for patients whose tumors have a type of alteration in the gene ROS1. About 1.5% of people diagnosed with non-small cell lung cancer have this alteration, and Pfizer’s Xalkori and Roche’s Rozlytrek are currently approved to target it.

• Bristol Myers acquired Augtyro through its $4 billion buyout of Turning Point Therapeutics, which specialized in targeted oral drugs for cancer. Bristol Myers believes Augtyro has an opportunity to roughly double the size of the ROS1 market, which the company has estimated to be around $500 million to $600 million, based on annual revenue from Xalkori and Rozyltrek.

Dive Insight:

The arrival of immunotherapies like Merck & Co.’s Keytruda and Bristol Myers’ Opdivo transformed the treatment of lung cancer. But for patients with uncommon mutations like ROS1, ALK, KRAS and EGFR, targeted drugs are a first choice for physicians.

The FDA approved Augtyro based on a trial that didn’t compare it to a placebo, and researchers knew what experimental drug they were using. Called TRIDENT-1, the trial tested Augtyro in non-small cell lung cancer patients with the ROS1 mutation whose disease had spread outside the lung.

In patients never treated with another ROS1-targeting drug, 79% saw their tumors shrink or disappear, and they continued to respond for a median of 34 months. In those who had received a ROS1-targeting drug previously, 38% had their tumors shrink or disappear, and they continued to respond for a median of 15 months.

The response rate in patients who had never been treated before was slightly higher than what was reported in testing of Xalkori and Rozlytrek. The duration of response appears longer, however, as Pfizer reported an 11 month median figure while Roche found that 38% of the Rozlytrek patients responded for 18 months or longer.

The FDA will only include Augtyro response data on its label. However, since Bristol Myers sought approval the TRIDENT-1, researchers have provided updated results on survival. Patients who had never received a ROS1-targeting drug went a median of 36 months without their disease progressing or dying.

While Augtyro isn’t expected to be among Bristol Myers’ top sellers, it’s part of a pipeline renewal project the company has undertaken as long-lived products like Revlimid, Abraxane and Eliquis hit or approach expiration of key patents and face generic competition.

New products like the heart drug Camzyos, psoriasis treatment Sotyktu and combination cancer immunotherapy Opdualag are expected to be much bigger contributors, each forecast to provide $4 billion in sales by 2030, according to Bristol Myers.