FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment
Betsy Goodfellow | March 4, 2024 | News story | Medical Communications | FDA, Johnson & Johnson, NSCLC, Oncology, Rybrevant
Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Rybrevant (amibantamab-vmjw) following a priority review.
The drug has been approved in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, which are detected via an FDA-approved test.
This approval converts the May 2021 accelerated approval of the drug to a full approval, following results from the confirmatory phase 3 PAPILLON study.
Kiran Patel MD, vice president of clinical development, solid tumours at Johnson & Johnson, commented: “We are redefining care for patients with NSCLC by advancing innovative regimens that can be used early, with the goal of extending survival. Rybrevant plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations. We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio.”
Joshua K Sabari MD, oncologist at NYU’s Langone’s Perlmutter Cancer Center, US, and study investigator, added: “When aiming for the best possible treatment outcomes, a targeted approach should be used in the first line for patients with EGFR exon 20 insertion mutations, as this is a commonly applied practice for patients with NSCLC harbouring other molecular driver alterations. The results observed in the PAPILLON study showed significant improvement in progression-free survival, supporting the use of this regimen as the potential standard-of-care in the first-line treatment of these patients.”
Betsy Goodfellow
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