Clovis Oncology, whose market value has plummeted by more than 80% over the past year, has secured a date with FDA advisers to make the case that its lung cancer treatment merits approval despite some disappointing data.
The FDA is putting an oral lung cancer drug from Boehringer Ingelheim on its inside track, promising to accelerate development of a new EGFR mutation-specific tyrosine kinase inhibitor that could quickly rival competing therapies from AstraZeneca and Clovis Oncology. And Boehringer is promising to hustle its way through a pivotal program with an eye to a near-term launch.
Cambridge, MA's Bind Therapeutics announced that a Phase II squamous histology non-small cell lung cancer cohort treated with its one of its candidates will progress to the next stage and complete enrollment at 40 patients, while the KRAS mutant arm of the trial will be terminated.
Roche picked up an accelerated FDA approval for its latest lung cancer therapy, planning to market the treatment for severely ill patients while building the clinical case for wider use.
So far this year, Bristol-Myers Squibb's Opdivo has grown about two times faster than Merck & Co.'s Keytruda, to $305 million and $159 million in third-quarter sales, respectively. And the FDA helped that trend along this month, when it gave Opdivo a new approval in non-small cell lung cancer several months early--just a week after Keytruda won its NSCLC green light.
Merck's immuno-oncology treatment Keytruda met just one of its two goals in a late-stage lung cancer trial, a rare clinical hiccup as it works to keep pace with rival Bristol-Myers Squibb and fortify its position as more contenders move toward the market.
A little more than a month ago Verastem had to mount a hasty defense of its lead drug defactinib (VS-6063) after an abstract hit the Twittersphere outlining poor efficacy and serious adverse events in its study for non-small cell lung cancer. This morning, though, the biotech could do little except acknowledge that the same drug had failed its most advanced study for mesothelioma.
Partners Amgen and Allergan say their knockoff of Roche's blockbuster Avastin proved itself on par with its reference product, putting the pair a step closer to biting into the cancer drug's billions in annual revenue.
Roche is spotlighting another success for its PD-L1 checkpoint drug atezolizumab, with company execs applauding a positive finish in a big mid-stage study in non-small cell lung cancer. The news follows a string of steady pipeline advancements for a drug that has emerged as the pharma giant's biggest single late-stage blockbuster contender.
Molecular diagnostics outfit Biodesix raked in $11 million in additional Series E financing to develop its blood-based test for non-small cell lung cancer, months after the company locked in new funds to support its commercialization efforts.