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J&J's Rybrevant Receives EU Approval for Expanded Use in NSCLC
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Johnson & Johnson (JNJ - Free Report) announced that the European Commission (EC) has approved its lung cancer drug Rybrevant (amivantamab) for expanded use.
The EC approved a type II extension of indication for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI).
JNJ's Stock Performance
Shares of JNJ have increased 3.9% so far this year compared with the industry’s growth of 27.1%.
Image Source: Zacks Investment Research
J&J's MARIPOSA-2 Study Data
The latest EC approval was based on data from the phase III MARIPOSA-2 study, which evaluated the safety and efficacy profile of the Rybrevant-chemotherapy combo in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC whose disease progressed on or after treatment with AstraZeneca’s (AZN - Free Report) blockbuster cancer drug Tagrisso (osimertinib).
Data from the study showed that treatment with Rybrevant plus chemotherapy reduced the risk of disease progression or death by 52% versus chemotherapy alone in the given patient population. Also, treatment with Rybrevant plus chemotherapy resulted in progression-free survival of 6.3 months compared to 4.2 months for chemotherapy alone – the primary endpoint of the study.
The approval in the EU was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency had recommended approval of the type II extension of indication of Rybrevant+ chemotherapy for the given patient population in July.
At present, Rybrevant is approved (conditional marketing authorization) in the EU for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Rybrevant is also approved in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations in Europe.
Recent Developments Related to JNJ's Rybrevant
Earlier this month, the FDA approved Rybrevant in combination with oral EGFR-TKI inhibitor, Lazcluze (lazertinib) as a first-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
This approval was based on data from the phase III MARIPOSA study, which evaluated the Rybrevant-Lazcluze combo against AstraZeneca’s Tagrisso in the given patient population.
A regulatory filing is currently under review in the European Union seeking marketing authorization for a similar indication.
Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) is currently under review in the United States 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 AZN’s Tagrisso.
J&J is also seeking the FDA’s approval for a subcutaneous formulation of Rybrevant for all currently approved or submitted indications of intravenous formulation of the drug.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 31.3%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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J&J's Rybrevant Receives EU Approval for Expanded Use in NSCLC
Johnson & Johnson (JNJ - Free Report) announced that the European Commission (EC) has approved its lung cancer drug Rybrevant (amivantamab) for expanded use.
The EC approved a type II extension of indication for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI).
JNJ's Stock Performance
Shares of JNJ have increased 3.9% so far this year compared with the industry’s growth of 27.1%.
Image Source: Zacks Investment Research
J&J's MARIPOSA-2 Study Data
The latest EC approval was based on data from the phase III MARIPOSA-2 study, which evaluated the safety and efficacy profile of the Rybrevant-chemotherapy combo in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC whose disease progressed on or after treatment with AstraZeneca’s (AZN - Free Report) blockbuster cancer drug Tagrisso (osimertinib).
Data from the study showed that treatment with Rybrevant plus chemotherapy reduced the risk of disease progression or death by 52% versus chemotherapy alone in the given patient population. Also, treatment with Rybrevant plus chemotherapy resulted in progression-free survival of 6.3 months compared to 4.2 months for chemotherapy alone – the primary endpoint of the study.
The approval in the EU was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency had recommended approval of the type II extension of indication of Rybrevant+ chemotherapy for the given patient population in July.
At present, Rybrevant is approved (conditional marketing authorization) in the EU for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Rybrevant is also approved in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations in Europe.
Recent Developments Related to JNJ's Rybrevant
Earlier this month, the FDA approved Rybrevant in combination with oral EGFR-TKI inhibitor, Lazcluze (lazertinib) as a first-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
This approval was based on data from the phase III MARIPOSA study, which evaluated the Rybrevant-Lazcluze combo against AstraZeneca’s Tagrisso in the given patient population.
A regulatory filing is currently under review in the European Union seeking marketing authorization for a similar indication.
Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) is currently under review in the United States 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 AZN’s Tagrisso.
J&J is also seeking the FDA’s approval for a subcutaneous formulation of Rybrevant for all currently approved or submitted indications of intravenous formulation of the drug.
Zacks Rank & Stocks to Consider
J&J currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , 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 Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 31.3%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.