The first drug from Eli Lilly's new-look oncology group gets speedy review as Bilenker's team hones focus
The first drug from Eli Lilly’s Loxo buyout is nearing the finish line.
The pharma giant has received priority review for its RET inhibitor selpercatinib, setting it up for an FDA decision sometime between July and September. That will give it a further leg up on Blueprint Medicines in the race to get the first of this new class of cancer drugs approved. Blueprint has yet to submit an NDA, although it plans to this quarter.
Selpercatinib, or LOX-292, produced a 68% response rate in 105 non-small cell lung cancer patients back in September, cementing its place at the top of Lilly’s new-look oncology group. The company bought Loxo hoping to restart a cancer division that had fallen far behind the rest of the industry. Then they hired Loxo’s former heads, including ex-CEO Josh Bilenker, to run the division, hoping — in that alchemist way Big Pharma and their biotech acquisitions often do – to keep the biotech’s nimble ingenuity alive, only with better resources.
An accelerated approval would be a major endorsement of the original $8 billion acquisition, although Blueprint will likely be not far behind. It’s difficult to compare trials, but they also demonstrated a response rate a little over 60% in a little more than 100 NSCLC patients. About 2% of NSCLC patients have a RET mutation.
Since his transition to cancer R&D chief, Bilenker has pared down old assets, including their $40 million collaboration with NextCure from 2018, and invested in ones that looked most promising. That includes four main clinical assets, two from Loxo and two from Lilly. From Loxo: selpercatinib and Loxo-305, their version of the second-generation, non-covalent BTK inhibitor several biotechs and Big Pharma companies are trying to develop. From Lilly: LY3484356, a selective estrogen receptor degrader, and LY3499446, their contribution to the KRAS race.
There’s also the CDK4/6 drug Verzenio, already approved for breast cancer, that the group is working to establish in combos, including with the KRAS drug.
We may get a closer read of the reorganization underway in oncology with Lilly’s upcoming Q4 review.