CHMP recommends RYBREVANT®? (amivantamab) in combination with LAZCLUZE®? (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer [Yahoo!...
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced risk of disease progression or death by 30 percent versus osimertinib monotherapy BEERSE, BELGIUM, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the Marketing Authorisation (MA) for LAZCLUZE ® ? (lazertinib), in combination with RYBREVANT ® ? (amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations. The CHMP has simultaneously recommended approval of a Type II extension of indication for amivantamab in the same combination regimen. "Lung cancer remains the leading cause of cancer-related deaths globally, and patients with EGFR-mutated advanced non-s
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JNJ
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- 10/15/24 - Beat
JNJ
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- 11/13/24 - Form 13F-HR
- 11/6/24 - Form 25-NSE
- 10/31/24 - Form 4/A
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