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.
If Roche had a drug-development trading card, its stats would look something like this: R&D budget of $9 billion, with 72 development programs, 19 late-stage studies and 12 candidates for near-term approval.