Johnson & Johnson's Rybrevant Scores Third FDA-Approval Of 2024 For Certain Type Of Inoperable Lung Cancer In Pretreated Patients

Thursday, the FDA approved Johnson & Johnson JNJ Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

The FDA approval is based on results from the Phase 3 MARIPOSA-2 study, which showed that Rybrevant plus chemotherapy reduced the risk of disease progression or death (progression-free survival [PFS]) by 52% compared to chemotherapy alone, the study’s primary endpoint.

Also Read: Johnson & Johnson Seeks FDA Approval For Muscle Weakness Drug And Gears Up Showdown With Argenx and UCB.

The median PFS for patients receiving Rybrevant plus chemotherapy was 6.3 months, compared to 4.2 months for chemotherapy alone.

Additionally, Rybrevant plus chemotherapy showed a confirmed overall response rate (ORR) of 53% compared to 29% with chemotherapy alone.

This approval marks the third new indication for Rybrevant this year, following the FDA approval of Rybrevant in combination with Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, based on the Phase 3 MARIPOSA study, and FDA approval of Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, based on the Phase 3 PAPILLON study.

In June, Johnson & Johnson submitted an FDA marketing application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration for all currently approved or submitted indications of intravenous (IV) Rybrevant.

The application is based on the Phase 3 PALOMA-3 study, in which the preliminary results showed a five-fold reduction in infusion-related reactions (IRR) with a five-minute administration of SC amivantamab.

Price Action: JNJ stock is down 0.18% at $164.52 at last check Friday.

Image by PDPics from Pixabay

Read Next:

• VinFast Hits Roadblock: Fails To Meet Q2 Earnings And Sales Expectations, Cautions On Challenging Macro EV Outlook.