J&J (JNJ) Seeks Expanded Use of Lung Cancer Drug Rybrevant
Johnson & Johnson JNJ announced that it submitted a supplemental biologics license application (sBLA) seeking approval for the expanded use of its cancer drug, Rybrevant (amivantamab-vmjw).
The sBLA seeks Rybrevant's approval in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) for patients whose disease has progressed on or after treatment with AstraZeneca’s Tagrisso (osimertinib).
The sBLA was based on data from the phase III MARIPOSA-2 study, which evaluated the safety and efficacy of Rybrevant plus chemotherapy in the given patient population.
Currently, Rybrevant is approved in the United States for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy in the United States. The European Medicines Agency had also granted conditional marketing authorization to Rybrevant for the same indication.
Shares of J&J have plunged 15.1% so far this year against the industry’s growth of 3.8%.
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In October 2023, the company presented data from the phase III MARIPOSA-2 study at the European Society for Medical Oncology 2023 Congress.
Data from the same showed that treatment with Rybrevant plus chemotherapy led to a significant improvement in progression-free survival (the primary endpoint) as compared with chemotherapy alone in patients with EGFR-mutated advanced NSCLC following prior osimertinib therapy.
We remind investors that another sBLA is seeking approval for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertion mutations.
Several other early to mid-stage studies are currently underway, evaluating Rybrevant in NSCLC.
Zacks Rank & Stocks to Consider
J&J currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Novo Nordisk A/S NVO, AbbVie Inc. ABBV and Acadia Pharmaceuticals Inc. ACAD, carrying a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have improved from $2.15 to $2.62. During the same period, earnings estimates for 2024 have moved up from $2.46 to $3.07. Year to date, shares of NVO have rallied 52.9%.
Earnings of Novo Nordisk beat estimates in two of the trailing four quarters, met the same once and missed on the other occasion. On average, NVO came up with a four-quarter earnings surprise of 0.58%.
In the past 60 days, estimates for AbbVie’s 2023 earnings per share have improved from $11 to $11.19. During the same period, earnings estimates for 2024 have moved up from $11.05 to $11.14. Year to date, shares of ABBV have lost 14.3%.
Earnings of AbbVie beat estimates in each of the trailing four quarters. On average, ABBV came up with a four-quarter earnings surprise of 2.49%.
In the past 60 days, estimates for Acadia Pharmaceuticals’ 2023 loss per share have narrowed from 41 cents to 34 cents. During the same period, earnings per share estimates for 2024 have moved up from 52 cents to 90 cents. Year to date, shares of ACAD have surged 44%.
Earnings of Acadia Pharmaceuticals beat estimates in two of the trailing four quarters and missed on the other two occasions. On average, ACAD came up with a four-quarter earnings surprise of 20.69%.
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