Pfizer, playing catch-up with Novartis, bags FDA approval for drug combo in lung cancer

Pfizer is expanding the reach of its BRAF-MEK combo as the pharma giant looks to further build up its oncology presence.

The FDA has approved Pfizer’s Braftovi and Mektovi for treating metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutations, the agency said Wednesday.

Pfizer reached this treatment setting late, though. The new approval comes more than six years after Novartis won the FDA’s go-ahead for its own BRAF-MEK combo, Tafinlar and Mekinist, in the same BRAF-mutant NSCLC setting.

In fact, the Novartis cocktail last year snagged a tumor-agnostic label to treat any advanced solid tumors with the BRAF V600E mutation following prior therapy or in patients who have no alternative treatment options.

BRAF represents one of the well-established biomarkers in NSCLC that can be treated with targeted therapies. Pfizer has several FDA-approved drugs for other types of NSCLC marked by genomic abnormalities, including Xalkori and Lorbrena for ALK-positive or ROS1-positive NSCLC, plus Vizimpro for EGFR-mutated disease. The BRAF V600E mutation accounts for about 2% of NSCLC cases.

Similar to the Novartis combo’s approval in 2017, Pfizer won over the FDA with tumor response data from a single-arm phase 2 trial. In the PHAROS study, the Pfizer regimen shrank tumors in 75% of 59 treatment-naïve patients and in 46% of 39 previously treated patients.

Separately, a Novartis trial showed a 61% response rate for Tafinlar and Mekinist in newly diagnosed patients and 63% in previously treated patients. The trials were different and too small to draw any conclusions about which therapy is better.

Still, with a much broader label, the Novartis combo boasts bigger sales. Last year, the Novartis drugs brought in $1.77 billion, growing 11% at constant currencies. The Pfizer medicines together generated $370 million, growing by 8% from the prior year.

Pfizer obtained Braftovi and Mektovi through its $11.4 billion acquisition of targeted oncology specialist Array BioPharma in 2019. The New York pharma has a history of M&A in oncology, including the $14 billion acquisition of Medivation in 2016 that gave it Astellas-partnered prostate cancer drug Xtandi.

As Pfizer’s top-selling cancer drug, Ibrance, comes under pressure from newer CDK4/6 inhibitors in breast cancer, the company was recently again at the dealmaking table. In March, Pfizer made a $43 billion bid for antibody-drug conjugate developer Seagen.

That deal recently hit an antitrust hurdle as the U.S. Federal Trade Commission requests more information to make a decision.