RARATIN, N.J. - Johnson & Johnson (NYSE: JNJ (NYSE:JNJ)) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a subcutaneous formulation of amivantamab, aimed at treating patients with non-small cell lung cancer (NSCLC).
This application is based on findings from the Phase 3 PALOMA-3 study, which demonstrated a significant reduction in infusion-related reactions and improvements in overall survival and progression-free survival when compared to intravenous administration.
The PALOMA-3 study, which included 418 patients, compared the pharmacokinetics, efficacy, and safety of subcutaneous amivantamab combined with lazertinib to that of intravenous amivantamab and lazertinib.
The results, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology, showed that the subcutaneous method had comparable response rates and was associated with a five-fold reduction in infusion-related reactions and a notably shorter administration time.
In addition to the PALOMA-3 results, the BLA submission incorporates data from the Phase 2 PALOMA-2 study, which supports dosing schedules of every two and every three weeks. Dr. Kiran Patel, Vice President, Clinical Development, Solid Tumors, at Johnson & Johnson Innovative Medicine, highlighted the potential of the subcutaneous option to transform the treatment experience for patients, oncologists, and nursing staff.
The application follows the recent FDA approval of RYBREVANT in combination with chemotherapy as the first treatment for NSCLC with EGFR exon 20 insertion mutations and a positive opinion for the same combination in Europe.
The BLA for the subcutaneous formulation of amivantamab seeks to extend its use for all indications currently approved or submitted for the intravenous form of RYBREVANT.
RYBREVANT, a bispecific antibody targeting EGFR and MET, is also being studied in multiple clinical trials for various NSCLC treatments, including the Phase 3 MARIPOSA study, which has been granted Priority Review by the FDA. Johnson & Johnson is committed to advancing healthcare innovation and is working closely with the FDA and global regulators on the review of these applications.
The information reported is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson has presented long-term data from its MonumenTAL-1 study, showing promising results for its multiple myeloma treatment, TALVEY®. Patients treated with TALVEY® showed high response rates and sustained responses, with a median duration of response of 17.5 months.
In legal developments, Johnson & Johnson has been implicated in opioid crisis settlements exceeding $46 billion, with law firms like Motley Rice receiving significant portions of a $2.13 billion legal fee pool.
On the analyst front, RBC Capital has maintained an Outperform rating on Johnson & Johnson stock, following the presentation of encouraging data at a recent analyst meeting. Johnson & Johnson's DePuy Synthes has also received FDA clearance for its VELYS Robotic-Assisted Solution for partial knee replacements.
Meanwhile, Citi has adjusted its price target for Johnson & Johnson to $180, maintaining a 'Buy' rating, following the finalization of Johnson & Johnson's acquisition of Shockwave Medical (NASDAQ:SWAV).
Lastly, Johnson & Johnson has been ordered to pay $260 million in an Oregon talc case, while also working on a proposed $6.48 billion settlement to resolve the majority of talc-related lawsuits. These are some of the recent developments concerning Johnson & Johnson.
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