US FDA approves J&J’s chemotherapy-free treatment for lung cancer

By Bhanvi Satija and Christy Santhosh

(Reuters) -The U.S. health regulator on Tuesday approved Johnson & Johnson (NYSE:)’s chemotherapy-free combination treatment for a type of non-small cell lung cancer, giving patients access to a therapy that could replace the current standard of care.

The approval allows the use of J&J’s cancer drug, Rybrevant, in combination with an older drug, lazertinib, as a first-line treatment for non-small cell lung cancer (NSCLC) patients with a mutated form of a gene called EGFR.

NSCLC is the most common type of lung cancer, and the EGFR mutation occurs in 10-15% of the cases in the United States, according to data from the American Lung Association.

The Food and Drug Administration’s decision is based on data from a late-stage study, in which J&J’s Rybrevant combination increased the time patients lived without their disease worsening, compared with AstraZeneca (NASDAQ:)’s blockbuster drug, Tagrisso.

Tagrisso is commonly used as a front-line treatment for NSCLC patients, followed by chemotherapy.

J&J’s Rybrevant is already approved for the treatment of NSCLC as a monotherapy and in combination with chemotherapy for patients with the EGFR mutation in the United States.

The company expects Rybrevant, which is among its newer cancer treatments, to generate more than $5 billion in peak sales.

Rybrevant disrupts growth of EGFR and another gene called MET to slow down or stop the spread of tumorous cells, while lazertinib inhibits their rapid reproduction.

The company will be ready to launch the combination “any second” after the FDA’s decision and is making arrangements that will support the launch, said Biljana Naumovic, a J&J executive who oversees the commercial strategy for the drugmaker’s oncology treatments.

“We are the first chemo-free therapy that comes in the frontline setting, in the space where we want to bring more survival and more life for the patients and around the world.”