Johnson & Johnson JNJ announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for the expanded use of the subcutaneous (SC) formulation of Rybrevant (amivantamab) in advanced EGFR-mutated non-small cell lung cancer (NSCLC).

The CHMP recommendation is for SC Rybrevant in combination with Lazcluze (lazertinib) for the first-line treatment of patients with advanced NSCLC with EGFR exon 19 deletion (ex19del) or L858R mutation. The CHMP also recommended marketing authorization for the SC formulation of Rybrevant as a monotherapy for treating adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

The European Commission had approved a combination of its intravenously administered Rybrevant plus Lazcluze for a similar use in Europe in December 2024.

In the past year, shares of J&J have lost 2.5% compared with the industry’s decline of 2.6%.

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CHMP Nod to JNJ's Rybrevant Based on Data From PALOMA-3 Study

The CHMP recommendation for the SC formulation of Rybrevant was based on positive data from the phase III PALOMA-3 study.

Data from the PALOMA-3 study showed that treatment with SC Rybrevant was non-inferior to intravenous (IV) Rybrevant, meeting both co-primary pharmacokinetics (PK) endpoints. The data also showed a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events.

Rybrevant is currently approved as an IV formulation, as a combination therapy and as a monotherapy for treating NSCLC across different lines of treatment and various mutations.

The SC formulation of Rybrevant cuts the administration time from hours to minutes and also reduces infusion-related reactions compared to the currently approved intravenous therapy.

CHMP's Nod for Expanded Use of AZN's Imfinzi

AstraZeneca AZN announced that CHMP has recommended approval for its blockbuster cancer drug Imfinzi (durvalumab) as a monotherapy for treating limited-stage small cell lung cancer (LS-SCLC) in adult patients whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

The FDA approved Imfinzi for a similar indication in December 2024.

In the past year, shares of AstraZeneca have rallied 7.3% against the industry’s decline of 2.6%.

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The latest CHMP recommendation for the expanded use of Imfinzi was based on data from the phase III ADRIATIC study.

Data from the phase III ADRIATIC study showed that treatment with Imfinzi reduced the risk of death by 27% as compared to placebo.

Additionally, treatment with Imfinzi reduced the risk of disease progression or death by 24% versus placebo.

Imfinzi is the global standard of care in the curative-intent setting of unresectable, stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy. It is also approved for extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries.

Imfinzi is a key revenue driver for AZN’s oncology portfolio, having generated sales worth $3.46 billion in the first nine months of 2024. Sales rose 22% year over year at constant exchange rates, driven by demand growth across all approved indications.

JNJ and AZN's Zacks Rank & Stocks to Consider

J&J and AstraZeneca have a Zacks Rank #3 (Hold) each.

Some better-ranked stocks in the biotech sector are Harmony Biosciences Holdings, Inc. HRMY and BioMarin Pharmaceutical Inc. BMRN, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Harmony Biosciences’ earnings per share have increased from $2.64 to $3.22 for 2025. In the past year, shares of HRMY have rallied 27.6%.

HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.

In the past 60 days, estimates for BioMarin’s earnings per share have moved up from $3.94 to $4.02 for 2025. In the past year, shares of BMRN have plunged 28.9%.

BMRN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 28.70%.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report

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