The Food and Drug Administration has granted accelerated approval to the latest in a growing group of cancer drugs designed to target genetic abnormalities with a high probability of producing a clinical effect.

The agency granted the accelerated approval Friday to Indianapolis-based drugmaker Eli Lilly’s Retevmo (selpercatinib) for advanced non-small cell lung cancer (NSCLC) and thyroid cancer with RET fusions and medullary thyroid cancer (MTC) with RET mutations, the FDA said. The FDA had granted priority review to Lilly’s application in January. The drug is the first RET inhibitor to win approval.

The accelerated approval was based on data from the Phase I/II LIBRETTO-001 clinical trial of the drug in RET-altered lung and thyroid cancers. Two Phase III confirmatory trials are underway one in first-line RET fusion-positive NSCLC and one in first-line RET-mutant MTC. Lilly acquired control of the drug last year when it bought Loxo Oncology, which has since been incorporated into Lilly Oncology.

Although Retevmo’s indication is not tumor-agnostic, it will still require finding patients with RET alterations. To that end, the company is relying on physicians using both tests they’ve institutionally developed as well as commercially available ones from companies like Roche’s Foundation Medicine. It also has collaborations with Thermo Fisher Scientific and Illumina to develop a companion diagnostic, though that is not required to find RET altered tumors for Retevmo.

“As there are more and more targeted agents available, doctors are wanting to find these alterations, and I think that testing will increase as we have additional drugs with high efficacy,” said Maura Dickler, vice president for late-stage development at Lilly Oncology, in a phone interview.

In terms of launch plans, although some companies have found themselves delayed due to the Covid-19 pandemic – notably Bristol-Myers Squibb in its delayed launch of the multiple sclerosis drug Zeposia (ozanimod) – Lilly is moving ahead with Retevmo. The company has invested in multiple digital and virtual channels like webinars and outreach through Doximity and Medscape to ensure physicians are aware of the approval, given that the pandemic has left its sales staff grounded.

“It’s maybe a different launch from what we would normally do,” Lilly Oncology President Anne White said in the same phone interview.

The drug’s list price will be $20,600 per month, which White said would be in line with other oral therapies. Out-of-pocket costs will vary depending on insurance plans, and the drug is being launched with a savings card and support programs, she added.

Data for the LIBRETTO-001 trial were presented at the 2019 World Conference on Lung Cancer in September showed a 68% overall response rate among 105 patients with previously treated RET fusion-positive NSCLC, along with an 85% ORR in patients with treatment-naive disease. Later that month, the company presented data at the European Society for Medical Oncology’s annual meeting showing a 56% ORR in pretreated RET-mutant MTC and a 62% ORR in pretreated RET fusion-positive thyroid cancer patients.

Blueprint Medicines also has a RET inhibitor, pralsetinib, in Phase I/II development for RET-altered NSCLC, MTC and other cancers and in Phase III development for RET fusion-positive NSCLC.

Photo: Michail_Petrov-96, Getty Images



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