Merck & Co. won U.S. approval to market its immunotherapy Keytruda for use in previously untreated lung cancer patients two months ahead of schedule.

Swiss drugmaker Roche Holding’s new immunotherapy Tecentriq won approval from U.S. health regulators as a second-line lung cancer treatment, a decision seen likely to erode Bristol-Myers Squibb’s position in this hotly contested market.

Merck scored a double hit with data showing Keytruda immunotherapy offered big benefits in previously untreated lung cancer patients, with or without chemo.

Recent clinical trial results are likely to lead doctors to treat more patients who have a common form of lung cancer with a Merck drug at the expense of a Bristol-Myers Squibb medication at least until more data emerges, oncologists and analysts say.

The outlook remains bright due to a favorable regulatory arena, support for biopharma-friendly legislation and development incentives, expanding scientific opportunities in key therapeutic areas such as immuno-oncology, and big pharma’s continued push to obtain innovation.

Dupilumab, Regeneron/Sanofi Dupilumab is the first systemic therapy to demonstrate positive Phase III results in patients with moderate-to-severe atopic dermatitis. The serious, chronic inflammatory skin disease is marked by widespread rash, itching and associated psychosocial comorbidities. Dupilumab inhibits interleukin-4 and interleukin-13, which are small anti-inflammatory proteins secreted by cells that are thought to play a […]

FDA gave Tecentriq accelerated approval to treat specific types of advanced bladder cancer.