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The plus combination chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC) in patients whose tumors harbor EGFR exon 20 insertion mutations, as determined by an approved diagnostic, the agency announced on Friday.

The action converts the bispecific antibody's accelerated approval -- initially only in the second-line setting -- to a full approval.

Amivantamab's indication in the first-line setting -- in combination with carboplatin and pemetrexed (Alimta) -- was based on results from the multicenter PAPILLON trial, a randomized open-label study involving 308 patients with these rare EGFR mutations that affect about 2% to 3% of all NSCLCs.

In the phase III study, progression-free survival improved from 6.7 months with carboplatin and pemetrexed alone to 11.4 months with the addition of amivantamab (HR 0.40, 95% CI 0.30-0.53, P<0.0001). Response rates also improved to 73% with amivantamab versus 47% with the chemotherapy combination alone.

While results on the secondary endpoint of overall survival were immature, the FDA noted that "no trend towards a detriment was observed."

"When aiming for the best possible treatment outcomes, a targeted approach should be used in the first line for patients with EGFR exon 20 insertion mutations, as this is a commonly applied practice for patients with NSCLC harboring other molecular driver alterations," said study investigator Joshua Sabari, MD, of NYU Langone's Perlmutter Cancer Center in New York City, in a from drugmaker Johnson & Johnson.

"The results observed in the PAPILLON study showed significant improvement in progression-free survival, supporting the use of this regimen as the potential standard-of-care in the first-line treatment of these patients," he added.

Amivantamab, an antibody that targets EGFR and MET, originally gained accelerated approval in 2021 for NSCLC patients with EGFR exon 20 insertion mutations whose disease progressed after standard platinum-based chemotherapy. It is now the only drug approved for these mutations, after Takeda last fall announced plans to withdraw mobocertinib (Exkivity) from the U.S. market following a failed confirmatory trial.

According to the FDA, adverse events that occurred in 20% or more of trial participants receiving amivantamab included "rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting." Grade 3/4 laboratory abnormalities occurring in at least 2% of patients included decreases in albumin, sodium, potassium, magnesium, white blood cells, hemoglobin, neutrophils, platelets, and lymphocytes; along with increased alanine aminotransferase and gamma-glutamyl transferase, Johnson & Johnson noted.

for amivantamab includes warnings and precautions for infusion-related reactions, interstitial lung disease/pneumonitis, dermatologic adverse events, ocular toxicity, and embryo-fetal toxicity.

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