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04-01-2019 | FDA | News

approvalsWatch

Atezolizumab, larotrectinib approvals announced by FDA

medwireNews: The US FDA has granted approval for use of atezolizumab alongside chemotherapy for some patients with nonsquamous non-small-cell lung cancer (NSCLC), while larotrectinib may now be used against solid tumors with the neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

The programmed cell death ligand 1 (PD-L1) inhibitor atezolizumab may be given in combination with bevacizumab, paclitaxel, and carboplatin as a first-line therapy for patients with metastatic NSCLC without EGFR or ALK alterations.

The decisions follows results from the IMpower150 trial which demonstrated a significant improvement in median overall survival and progression-free survival with the four-drug regimen compared with a three-drug protocol of atezolizumab, carboplatin, and paclitaxel or a control arm of carboplatin, paclitaxel, and bevacizumab.

Fifteen percent of patients discontinued atezolizumab  because of side effects, most commonly pneumonitis. Of note, 36% of patients experienced antidrug antibodies to the PD-L1 inhibitor, the majority of whom did so after the first dose, and this reaction was not associated with survival.

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In the second tissue-agnostic FDA approval for cancer treatment, patients with solid tumors positive for a NTRK gene fusion and no known resistance mutation may now be given the tropomyosin kinase receptor inhibitor larotrectinib.

For patients with recurrent or metastatic disease, or for whom surgery would result in severe morbidity, the oral agent is recommended at a twice daily dose of 100 mg for adults and 100 mg/m2 for children.

The decision is based on results from the LOXO-TRK-14001, SCOUT, and NAVIGATE clinical trials, showing the agent’s efficacy in unresectable or metastatic disease. Common side effects include gastrointestinal adverse events, dizziness, and cough.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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