03-07-2025
Sunvozertinib Wins Approval for EGFR-Mutated NSCLC
The FDA has granted accelerated approval to sunvozertinib (Zegfrovy, Dizal Pharmaceutical) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor ( EGFR) exon 20 insertion mutations that's progressed on or after platinum-based chemotherapy.
The agency also approved Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic to detect the mutations.
The oral EGFR inhibitor is the first small molecule approved in the US for the indication; it was previously approved in China.
The intravenous bispecific antibody amivantamab-vmjw (Rybrevant, Johnson & Johnson) also carries a second-line indication for EGFR exon 20 insertion mutated advanced/metastatic NSCLC, as well as a first-line indication with carboplatin and pemetrexed.
Dizal is going for a first-line indication, too. The company recently announced completion of enrolment in a phase 3 trial pitting sunvozertinib against platinum-based chemotherapy for the upfront treatment of EGFR exon 20 insertion mutated NSCLC.
The new second-line approval was based on WU-KONG1B, a multinational dose finding trial. All subjects had previous platinum-based chemotherapy and 43.4% had also received immunotherapy; 13.3% had been on amivantamab.
Among 85 patients on 200 mg sunvozertinib daily, the overall response rate was 46% and the duration of response was 11.1 months.
Labelling warns of the possibility of interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic issues, ocular toxicity, and embryo-fetal toxicity. Diarrhea, skin rash, and creatine phosphokinase increase were the most common drug-related treatment emergent adverse events in the trial, with most events being grade 1 or 2.
The recommended dose is 200 mg orally once daily with food until disease progression or unacceptable toxicity.
M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@
