Few productivity metrics in biopharma measure up to the annual rate of new drug approvals. So now that the FDA has come through with only 13 novel approvals in the first half of the year, well off the pace of 39 new approvals in 2012, there's some handwringing going on.
Dako has been on a tear with big-name companion diagnostics partnerships, and its latest one might end up being the most lucrative: The company has received FDA approval for two tests to be paired with Kadcyla, Roche's soon-to-explode breast cancer drug.
Roche's Genentech picked up FDA approval for its late-stage breast cancer therapy Kadcyla, formerly T-DM1, which uses antibodies to deliver cancer drugs directly to the offending cells.
The FDA gave approval to T-DM1, which will be marketed as Kadcyla, for patients with HER2-positive, late-stage (metastatic) breast cancer.
The FDA today approved T-DM1, a breakthrough antibody drug conjugate from Roche/Genentech widely expected to quickly become a new blockbuster treatment for breast cancer.
A new approach to treating HER2-positive breast cancer, the antibody-drug conjugate is seen as a significant advance for patients. FDA put T-DM1 up for priority review, with a decision due by February 26.
Roche has gained the inside track in the final lap of a long and expensive race to win an FDA approval for the armed antibody T-DM1, a new approach to treating HER2-positive breast cancer that marks a significant advance for patients.
Now that Roche has pushed Perjeta (pertuzumab) out into the market to grow sales for its breast cancer franchise, the pharma giant is confidently positioning T-DM1 as its next potential oncology blockbuster most likely to succeed with regulators.
Roche and ImmunoGen's trastuzumab emtansine (T-DM1) slashed the risk of death by almost a third compared with standard treatment in the EMILIA Phase III trial in women with advanced breast cancer.
Investigators behind the big T-DM1 breast cancer program took the lid off the last big data box from its pivotal study this morning, revealing that the armed antibody delivered a 32% reduction in the risk of death among patients in the pivotal Phase III study when compared to the standard-of-care arm.