Johnson & Johnson JNJ announced that the FDA approved the combination of its intravenously administered EFGR/MET inhibitor Rybrevant (amivantamab) and oral EGFR-TKI inhibitor Lazcluze (lazertinib) as a chemotherapy-free treatment for a type of lung cancer.

Following the FDA decision, Rybrevant combined with Lazcluze is approved as a first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

This approval is based on data from the phase III MARIPOSA study, which evaluated the Rybrevant-Lazcluze combo against AstraZeneca’s AZN blockbuster oncology drug Tagrisso in patients with the above indication. Data from the study showed that treatment with the JNJ combination therapy reduced the risk of disease progression or death by 30% compared with AZN’s Tagrisso. Patients who took the combo achieved a median duration of response (mDOR) that was nine months longer than those treated with Tagrisso.

Per J&J, this latest FDA approval also makes the Rybrevant-Lazcluze combo the first and only chemotherapy-free regimen, which demonstrated superiority over Tagrisso in the above indication.

A regulatory filing is currently under review in the European Union seeking marketing authorization for a similar indication, also supported by data from the MARIPOSA study.

Through this latest approval, management intends to take the crown from the AstraZeneca drug, which is the current standard of care for EFGR-mutated NSCLC. However, that may be tough given AstraZeneca has also been evaluating the combination of Tagrisso plus chemotherapy compared with Tagrisso alone in the above indication. Data from a late-stage study released last year showed that the Tagrisso-chemotherapy combination reduced the risk of disease progression or death by 38%.

Shares of J&J have inched up 2.2% year to date compared with the industry’s 26.1% growth.

This is the second FDA approval for Rybrevant this year. Earlier in March, the FDA approved the combination of Rybrevant with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

Rybrevant is also approved as a single agent for treating adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.

As of Aug 20, the FDA is reviewing J&J’s two supplemental biologics license application (sBLA) filings, which seek label expansion for Rybrevant.

The first sBLA, filed last November, seeks the FDA’s approval for Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) as a treatment for patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations whose disease has progressed on or after receiving AstraZeneca’s Tagrisso. A similar filing was submitted in the EU last November. Data from the late-stage MARIPOSA-2 study supports both filings.

The second sBLA, filed in June, seeks the FDA’s approval for a subcutaneous formulation of Rybrevant for all currently approved or submitted indications of intravenous formulation of the drug. Management claims that the FDA granted a priority designation to this filing last week.

Zacks Rank & Key Picks

J&J currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the overall healthcare sector include Arcturus Therapeutics ARCT and Fulcrum Therapeutics FULC. While Fulcrum sports a Zacks Rank #1 (Strong Buy) at present, Arcturus carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, shares of Fulcrum Therapeutics have surged 39.6%.

Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.

In the past 60 days, estimates for Arcturus Therapeutics’ 2024 loss per share have improved from $4.39 to $2.60. Estimates for 2025 have improved from a loss of 45 cents to earnings of 21 cents per share during the same period. Year to date, shares of Arcturus Therapeutics have lost 32.6%.

Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters. Arcturus delivered a four-quarter average earnings surprise of 56.73%.

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