Following May 2020’s seven FDA approvals in non-small cell lung cancer, May 2021 brought only a pair of new NSCLC agents. However, these two drugs are significant because they were the first to gain FDA approvals for their specific indications. According to Zitter Insights research, the drugs should have good uptake among payers.
On May 21, the FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Rybrevant (amivantamab-vmjw), a bispecific antibody for the treatment of adults with NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-
approved test. The agency gave the intravenous infusion priority review and breakthrough therapy designation.
One week later on May 28, the FDA gave accelerated approval to Amgen Inc.’s Lumakras (sotorasib) for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one systemic therapy. This is the first targeted therapy for tumors with any KRAS mutation that the agency has approved. The FDA gave the drug priority review, as well as breakthrough therapy, fast track and orphan drug designations.
For the Managed Care Oncology Index: Q1 2021, between Feb. 26, 2021, and April 9, 2021, Zitter Insights polled 40 commercial payers with 132.2 million covered lives. Respondents covering 77% of lives said they planned to manage Rybrevant to label within six months of the survey period, those with 8% of lives said they expected to cover it more restrictively than its label, and payers covering 15% of lives said they likely would cover it without requiring prior authorization.
Zitter Insights and AIS Health are MMIT companies.
For Lumakras — previously known as AMG 510 — payers covering 83% of lives expect to manage it to label within six months of its approval (see chart below). Payers expecting to manage it more restrictively than its label plan to have a third-party vendor assess the agent compared with its clinical trial outcomes.
For more information on the Zitter data, contact Jill Brown Kettler at email@example.com.