News briefing: AbbVie and Roche's Venclexta scores another FDA OK; ImmunoGen nabs China deal with $40M cash
AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.
The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.
In the first Phase III, enrolling 431 patients, researchers found that Venclexta with azacitidine showed a 34% reduction in mortality compared to azacitidine alone, with overall survival reaching an average 14.7 months against 9.6 months. Those in the trial arm also saw a complete remission rate of 37% compared to just 18% for patients on azacitidine with placebo.
The second Phase III combined Venclexta with low-dose cytarabine and examined 211 patients. Venclexta’s combo did not significantly improve overall survival, but showed a complete remission rate of 27% whereas the low-dose cytarabine arm saw only a 7.4% rate.
Venclexta had previously been approved to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma back in 2018. That approval is for second-line treatment and combines Venclexta with Rituxan. — Max Gelman
ImmunoGen adds $40M, a China deal to its comeback story
ImmunoGen’s once-rejected antibody-conjugate is getting star treatment in China, picking up $40 million in cash from its new partner, Huadong Medicine.
The deal comes a year and a half after Immunomedics smashed records with a China deal for its own once-rejected ADC, which later scored an FDA OK and paved the way for a $21 billion buyout by Gilead.
With ImmunoGen’s collaboration, Huadong gets the rights to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau and Taiwan while the US developer is free to market it in the rest of the world.
Although the drug failed an initial Phase III in ovarian cancer, ImmunoGen is betting on its potential for a key population of platinum-resistant patients.
Huadong is on the hook for an additional $265 million in milestones in addition to royalties. — Amber Tong