A groundbreaking cancer drug nabs fast OK, giving Eli Lilly boasting rights as a rival speeds close behind
Eli Lilly $LLY has scored the fast FDA approval it was gunning for when the pharma giant plunked down $8 billion to acquire Loxo Oncology back at the beginning of 2019. Regulators stamped their OK on selpercatinib, which can now be marketed as Retevmo to patients suffering from 3 different types of cancers all driven by the same gene alteration.
The approval marks another win for advocates of rapid development, with the Loxo team jumping from their first treatment to an approval on Phase I/II data in 3 short years. And it comes just 3 months after the FDA’s cancer group handed Lilly a priority review, indicating that the agency still finds it easy to reward advances in the field with speedy answers — despite the pandemic.
For Lilly, the drug OK also marks a rare first place finish, but Blueprint Medicines $BPMC is expected to quickly counter with new data at ASCO on a rival that is one step behind the pharma giant.
The pharma player got the marketing ball rolling with a $20,600 per month price on the therapy.
But they don’t have a lock on best-in-class status. As Steve Scala at Cowen noted Monday morning:
The label contains positives (line agnostic, increased efficacy in thyroid cancer) and negatives (safety warnings including liver monitoring, incremental downtick in lung efficacy). All told, the label is incrementally worse than hoped. Long-term durability data is now more important.
The FDA action covers RET fusion-positive non-small cell lung cancer and thyroid cancer, along with RET-mutant medullary thyroid cancer. In the absence of an approved test to spot the alteration, Lilly suggests using biomarkers to identify patients.
That is no easy proposition, as only 2% of NSCLC patients will be included. But it’s a large enough group to push the field toward more testing. It also helps that Novartis just got an OK for capmatinib a few days ago, adding another drug used on the basis of a gene alteration that drives cell proliferation. As more of these drugs are approved, testing and sequencing will grow more common, allowing for better outcomes for all.
Blueprint is also likely to help that process if their next round of data for pralsetinib — now under FDA review — in RET fusion positive NSCLC highlights positive results. An application for RET-mutant medullary thyroid cancer is expected any week now.
Andrew Berens at SVB Leerink has been tracking the competition from Blueprint’s perspective, and recently noted how the matchup will be scored based on ASCO data:
We expect investor focus (on pralsetinib) to be on DOR relative to selpercatinib, which has shown median DOR of 20.3 months. However, some investors are focused on the median PFS as the relative benchmark of efficacy, with LOXO’s selpercatinib showing 18.4 months at WCLC 2019.
The FDA action on Friday serves as further validation for Lilly’s decision to turn over the oncology group to the Loxo team, led by Josh Bilenker. Lilly’s cancer team has had a lackluster performance record over the years, which Bilenker’s group was brought on to remedy. Since then, they’ve been cleaning up the pipeline and prepping new deals as Lilly looks to join big players like GSK and Sanofi, which are looking to turn things around with some fast-action cancer plays.