Johnson & Johnson JNJ announced that the FDA approved a combination therapy involving EFGR/MET inhibitor Rybrevant (amivantamab) for expanded use in certain patients with non-small cell lung cancer (NSCLC).

With this nod, Rybrevant combined with standard-of-care chemotherapy (carboplatin and pemetrexed) is approved for treating patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after receiving with an EGFR TKI inhibitor. This combination therapy was approved for a similar indication in the European Union last month.

This latest FDA approval is based on data from the phase III MARIPOSA-2 study, which evaluated the safety and efficacy profile of the Rybrevant-chemotherapy combo in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC whose disease progressed on or after treatment with AstraZeneca’s AZN blockbuster cancer drug Tagrisso (osimertinib).

The study achieved its primary endpoint — treatment with the Rybrevant-chemotherapy combination reduced the risk of disease progression or death by 52% versus chemotherapy alone in the given patient population.

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Recent Developments Related to JNJ's Rybrevant

This is the third FDA approval for Rybrevant this year. Last month, the agency approved the combination of Rybrevant and oral EGFR-TKI inhibitor Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR ex19del or exon 21 L858R substitution mutations. In March, the FDA approved the combination of Rybrevant and chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

Rybrevant is approved as a single agent for treating adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.

Through these approvals, the J&J drug intends to take on AstraZeneca’s Tagrisso, which is the current standard of care for EFGR-mutated NSCLC.

In June, J&J submitted a regulatory filing with the FDA, which seeks approval for a subcutaneous formulation of Rybrevant for all currently approved or submitted indications of the drug. Management claims that the FDA granted a priority designation to this filing last month.