J&J Wins FDA Nod for Subcutaneous Version of NSCLC Drug Rybrevant

Johnson & Johnson JNJ announced that the FDA has approved the subcutaneous (under the skin or SC) formulation of its EGFR/MET inhibitor, Rybrevant (amivantamab). This version, which will be marketed as Rybrevant Faspro, is approved across all indications for which the drug’s intravenous (into the vein or IV) version is already approved.

Both Rybrevant and Rybrevant are approved — either as a single agent or combination therapy — for treating non-small cell lung cancer (NSCLC) across different treatment settings and various mutations. The drugs are currently approved for a total of four indications in NSCLC.

A major advantage offered by Rybrevant Faspro over the IV formulation is improved patient convenience. Delivering a drug SC instead of IV can significantly reduce administration time. Per J&J, the SC version can be administered to patients in as little as five minutes compared with the IV formulation, which takes up to an hour. This also likely eases the burden on healthcare facilities, making treatment more accessible and potentially boosting adoption rates.

With this approval, J&J is now in a better position to take on AstraZeneca’s AZN Tagrisso, which is the current standard of care for EGFR-mutated NSCLC. Although data from one of the company’s late-stage studies have shown that treatment with a combination therapy involving the drug outshines the AZN drug, the latter’s convenience as an oral pill remained a major advantage over the IV-administered Rybrevant.

The FDA’s decision is supported by data from the late-stage PALOMA-3 study, which showed that treatment with Rybrevant Faspro was at least as effective as the IV version. This approval comes just a year after the agency rejected the initial filing of the drug due to manufacturing concerns. A similar approval for the SC version of the drug was secured earlier this year in the EU, also supported by data from the PALOMA-3 study.

The SC version of Rybrevant has been developed using Halozyme Therapeutics’ HALO proprietary drug delivery technology.

JNJ Stock Performance

Shares of J&J have surged more than 45% this year so far compared with the industry’s 16% growth.

J&J Chases $50B Goal in Oncology Sales

The company has a strong presence in oncology, with extensive expertise in blood cancers and solid tumors. This segment now comprises around 27% of its total revenues. Its oncology sales rose nearly 21% year over year in the first nine months to $18.52 billion, driven by strong market growth and share gains from key products such as multiple myeloma treatment Darzalex and prostate cancer drug Erleada.

New cancer drugs, such as Carvykti, Tecvayli, Talvey and Rybrevant, along with Lazcluze, contributed significantly to growth as they witnessed strong launches.

Based on this momentum, J&J has set an ambitious target to reach $50 billion in oncology sales by the end of this decade. While this goal may seem overly optimistic, it does not appear unachievable. In the five years from 2019 to 2024, J&J’s oncology sales doubled from $10.7 billion to $20.8 billion. To attain the $50 billion target over the next five to six years, the company needs to more than double its sales from 2024 levels.

J&J seems quite confident of the target, citing strong growth in its marketed cancer drugs and new launches like Inlexzoh (TAR-200) in high-risk non-muscle invasive bladder cancer and the subcutaneous formulation of Rybrevant plus Lazcluze for advanced EGFR-mutated non-small cell lung cancer.

The company is also building its oncology pipeline through inorganic growth strategies. Last month, it announced a definitive agreement to acquire the clinical-stage biotech Halda Therapeutics for $3.05 billion in cash. This deal aims to strengthen J&J’s broader oncology pipeline, mainly in prostate cancer, where it already has a strong presence with drugs like Zytiga, Erleada and Akeega.

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JNJ’s Zacks Rank

J&J currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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