Amivantamab-vmjw inotenderwa neUSFDA yeEGFR exon 20 yekuisa-yakashandurwa isiri-diki cell kenza yemapapu zviratidzo.

Amivantamab-vmjw inotenderwa neUSFDA yeEGFR exon 20 yekuisa-yakashandurwa isiri-diki cell kenza yemapapu zviratidzo.

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The Food and Drug Administration yakabvumira amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) pamwe chete necarboplatin uye pemetrexed musi waKurume 1, 2024. Varwere vane epidermal growth factor receptor (EGFR) exon 20 insertion mutations, yakaonekwa neFDA-yakatenderwa. bvunzo, vanokodzera kurapwa uku semushonga wekutanga wepanzvimbo yepamusoro kana metastatic isiri diki cell lung cancer (NSCLC).

Yakatenderwa neFDA kuti ishandiswe pavarwere vakuru vane nharaunda yepamusoro kana metastatic NSCLC vaive neEGFR exon 20 yekuisa shanduko, iyo inogona kusimbiswa neFDA-yakatenderwa bvunzo, uye vane mamiriro akawedzera mushure mekurapwa kweplatinum. Iyo FDA yakatopa kukurumidza kubvumidzwa kweichi chinangwa.

Iyo PAPILLON kuyedza (NCT04538664) yakatarisa kuti yakashanda sei. Yaive yakasarudzika, yakavhurika-label, multicenter kudzidza nevarwere ve308 vaive neEGFR exon 20 yekuisa mutations. Varwere vakaiswa zvisina tsarukano muchiyero che1: 1 kuti vagamuchire amivantamab-vmjw ine carboplatin uye pemetrexed kana carboplatin uye pemetrexed.

Chiyero chekutanga chekubudirira kwaive kufambira mberi-kusina kupona (PFS) yakaongororwa nebofu yakazvimiririra yepakati wongororo (BICR), nekupona kwese (OS) seyakakosha yechipiri yekupedzisira. A hazard ratio ye0.40 (95% CI: 0.30–0.53; p-value<0.0001) yakaratidza kuti amivantamab-vmjw pamwe necarboplatin uye pemetrexed yakavandudza zvakanyanya kufambira mberi-kusina kupona kana ichienzaniswa necarboplatin uye pemetrexed chete. Kupona kwepakati-pasina kupona (PFS) kwaive nemwedzi ye11.4 ine 95% yenguva yekuvimba (CI) ye9.8 kusvika 13.7 mune rumwe ruoko, uye 6.7 mwedzi ine 95% CI ye5.6 kusvika 7.3 mune rumwe ruoko.

Kunyange zvazvo huwandu hwehuwandu hwekupona hwakanga husina kunyatsogadzirwa pakuongorora kwemazuva ano, ne 44% chete yekufa kwakagara kwataurwa kwakashumwa kuongororwa kwekupedzisira, pakanga pasina chiratidzo chemaitiro asina kunaka.

Iwo akanyanya kukonzeresa (≥20%) aisanganisira mapundu, huturu hwezvipikiri, stomatitis, mhinduro inoenderana nekuwedzera, kuneta, edema, kupererwa nezano, kuderera kwekuda kudya, kuda kurutsa, COVID-19, manyoka, uye kurutsa.

Huremu hwemuviri wemurwere hunotaridza chipimo chinokurudzirwa cheamivantamab-vmjw. Tarisa kune mirairo yemirairo yedosaiti chaiyo ruzivo.

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