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J&J (JNJ) Files BLA for Lung Cancer Candidate Amivantamab

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Johnson & Johnson (JNJ - Free Report) announced that it has submitted a biologics license application (“BLA”) to the FDA for its investigational, fully human EGFR-MET bispecific antibody, amivantamab. The BLA is seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (“NSCLC”) with EGFR exon 20 insertion mutations, whose disease has progressed on/after platinum-based chemotherapy.

The BLA submission for amivantamab was based on data from the monotherapy arm of the phase I CHRYSALIS study, which evaluated amivantamab as a monotherapy as well as in combination with third-generation tyrosine-kinase inhibitor lazertinib in advanced NSCLC.

Per the press release, the company has established an expanded access program in the United States for patients aged 18 year and above, who may be eligible to get access to amivantamab while the application is under review in the region.

Shares of J&J have inched up 2.2% so far this year compared with the industry’s increase of 1.6%.

price chart for JNJ

We note that in 2012, Janssen, J&J’s subsidiary, entered into a collaboration with Danish biotech company Genmab A/S (GMAB - Free Report) for developing bispecific antibodies using the latter’s proprietary DuoBody technology platform. The BLA for amivantamab marks the first regulatory filing for such a product candidate which has been developed using Genmab’s DuoBody technology platform.

Meanwhile, amivantamab, upon potential approval, is likely to face stiff competition as the NSCLC market is highly crowded. Several established drugs are already approved to address the given indication.

Pfizer’s (PFE - Free Report) Vizimpro is approved for treating previously untreated EGFR-mutated NSCLC patients. Several other therapies are also approved for treating similar indication including AstraZeneca’s (AZN - Free Report) Tagrisso. Meanwhile, Eli Lilly’s Cyramza was approved in United States for first-line EGFR mutation positive NSCLC in May 2020.

Zacks Rank

J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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