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J&J submits BLA for Amivantamab to USFDA

Global pharmaceutical giant, Johnson & Johnson has developed a new subcutaneous (SC) form of amivantamab and submitted it to the US Food and Drug Administration (FDA) for a biologics licence. People with non-small cell lung cancer (NSCLC) and specific genetic abnormalities, such as EGFR exon 19 deletion or L858R mutations, should be eligible for this new disease category. This feedback has the potential to alter the treatment of these individuals.

At the 2024 ASCO Annual Meeting, researchers presented the findings of the Phase 3 PALOMA-3 trial, which showed that amivantamab administered subcutaneously (SC) is just as efficacious as intravenously (IV). Response rates were similar across the two formulations; however, the SC formulation had several benefits, including shorter dosing intervals, fewer infusion-related adverse effects, and better overall survival rates. 

The usual method of treating EGFR-mutated non-small cell lung cancer usually entails intravenous injections of RYBREVANT, as pointed out by Dr. Kiran Patel, Johnson & Johnson's VP of clinical development for solid tumours. This new SC option, which only takes five minutes to deliver, is a huge step forward in treatment and has the ability to change the way physicians, nurses, and patients all think about patient care. He was quite excited about the prospect of working with the Food and Drug Administration and other worldwide regulatory bodies to examine these applications. 

The Biologics Licence Application (BLA) incorporates the Phase 2 PALOMA-2 trial data. This trial assessed the SC version in different treatment scenarios where the IV version is already in use. Submitting this information will help with dosage schedules, which are every two to three weeks. 

Recent important events for RYBREVANT IV include positive comments from the EU and approval by the FDA to be used with other drugs in people who have EGFR exon 20 insertion mutations.

418 patients were asked to take part in the PALOMA-3 study to look into the safety, effectiveness, and distribution of amivantamab and lazertinib when given intravenously vs. subcutaneously. According to these results, the SC version might provide a more feasible and efficient method of treating the illness. 

One of the main goals of PALOMA-2 was to find out how well a SC formulation worked when used with lazertinib and other treatments to treat advanced non-small cell lung cancer.

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