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The results of the randomized Phase III ADAURA trial was unblinded early due to "overwhelming efficacy" in lung cancer patients.
The approval follows another recent approval for the two Bristol Myers Squibb agents without chemotherapy indicated for patients with PD-L1 scores of 1 percent or above.
ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).
The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
Bristol Myers Squibb is hoping that the durable responses seen with the combined immunotherapy drugs will convince doctors to prescribe it for their patients.
One cohort will involve NSCLC patients with MET exon 14 skipping mutations, while two other cohorts will enroll patients with solid tumors with MET amplifications and fusions.
In a Phase I trial, non-small cell lung cancer patients with exon 20 insertions experienced durable responses with amivantamab.
The latest approval is immunotherapy Tecentriq's fourth indication in non-small cell lung cancer and fifth indication in lung cancer.
The agency granted breakthrough therapy designation to the antibody-drug conjugate based on data from the ongoing Phase II DESTINY-Lung01 trial.
Clinicians will be able to use the assay to help identify patients with metastatic NSCLC for treatment with nivolumab and ipilimumab.