As of Friday, Roche has a new FDA approval in hand for lung cancer treatment Alecensa--and with it, it's about to go head-to-head with its crosstown rival.
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.
Pfizer's Xalkori is already used to treat patients with metastatic non-small cell lung cancer whose tumors are ALK-positive. But now it's on its way to snagging a speedy nod in another group of NSCLC patients, too.
Pfizer isn't among the leaders in the hot immuno-oncology field. But the company is friends with one of them--Merck. And now, Pfizer has tied yet another cancer treatment to Merck's IO coattails.
Pfizer said its targeted cancer drug Xalkori trounced chemotherapy in a trial of previously untreated patients with a particular type of lung cancer. The study showed for the first time that up-front treatment with Xalkori staves off cancer growth better than other treatments in patients whose tumors test positive for ALK-gene abnormalities.
Clinically effective but not cost-effective. That's what U.K. watchdogs have determined about Pfizer's targeted lung cancer drug, Xalkori. Despite a discount offer from Pfizer, the National Institute for Health and Care Excellence still believes Xalkori isn't a good value.
In the past, the U.K.'s cost-effectiveness gatekeeper has shown that it will bend preliminary draft guidance decisions if the price is right. But for Pfizer, which slashed costs on its targeted lung cancer drug Xalkori in hopes of gaining recommendation for its use in Britain's National Health Service, that price wasn't low enough.
The labeling logo is designed to encourage doctors and patients to report side effects, as part of a new effort to more closely monitor drug safety. The list of 100-plus products includes all new drugs and biologics approved since January 2011.
The well-armed German pricing gatekeepers have dismissed two more Big Pharma drugs. Pfizer's ($PFE) lung cancer treatment Xalkori and the Bristol-Myers Squibb ($BMY)/AstraZeneca ($AZN) diabetes drug Komboglyze both got an initial thumbs-down from the Institute for Quality and Efficiency in Health Care (IQWiG).
Computer-designed drugs have come of age. More than two decades after industry pioneer Joshua Boger set sail from Merck to start Vertex Pharmaceuticals ($VRTX) to advance structure-based drug design, the industry has seen multiple drugs discovered with the help of computers reach the finish line with FDA approvals.