Merck has won the frenzied race to secure the first FDA approval for a new breed of cancer treatment, clearing the way for a U.S. launch and a scramble for dominance in a field expected to peak at nearly $35 billion a year.
GlaxoSmithKline is touting stellar Phase III results for an in-development combo therapy for melanoma, saying its treatment beat out Roche's Zelboraf in overall survival and led independent advisers to recommend an early end for the study.
Roche and biotech partner Exelixis say their melanoma-fighting combination therapy met its primary endpoint in Phase III, clearing the way for an FDA application and giving the latter company a boost in its share value.
Bristol-Myers Squibb plans to submit its closely watched cancer candidate nivolumab for FDA approval to treat melanoma next quarter, outpacing analysts' expectations and setting the stage for a duel with Merck's rival drug.
South San Francisco biotech Exelixis and partner Roche say their in-development combo treatment for melanoma extended survival in an early-stage trial, setting the stage for Phase III results that could make or break the treatment's future.
After a string of promising late-stage results, Amgen's cancer-fighting viral vaccine failed to extend patients' lives at a statistically significant rate, missing a secondary endpoint and marking the first blemish on the biotech's top cancer prospect.
A new round of late-stage data on Amgen's cancer-fighting viral vaccine talimogene laherparepvec, better known as T-Vec, found that about two-thirds of the tumors injected with T-Vec shrank 50% or more. And the same effect was seen in about a third of all uninjected tumors in the skin and lymph nodes, providing an indication that the treatment is triggering the desired immune system effect.
According to new research published online Monday at the Journal of Clinical Oncology, 63% of the patients taking the immunotherapy were alive after one year and 43% were still alive after two years on the drug. And the researchers say that the durable response was also reflected in patients who had stopped taking the drug.
Combination cancer therapies are all the rage these days in the oncology field. Now two of the giant players in the cancer R&D arena have decided to match their top prospects to see if they can make a bigger impact on melanoma.
In the latest trove of promising Phase III data for Amgen's T-Vec, the cancer-fighting virus increased overall survival by four months compared to standard growth factor therapy, driving optimism that the drug can win approval and make some noise in the melanoma market.