FDA Accepts Application for Frontline Nivolumab/Ipilimumab in TMB-High NSCLC

Excerpt:

“The FDA has accepted a supplemental biologics license application (sBLA) for the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) for the frontline treatment of patients with advanced non–small cell lung cancer (NSCLC) with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb), according to Bristol-Myers Squibb (BMS), the manufacturer of both immune checkpoint inhibitors.

“The sBLA is based on findings from the phase III CheckMate-227 trial presented at the 2018 AACR Annual Meeting and published in the New England Journal of Medicine, in which the 1-year progression-free survival (PFS) rate was 43% for patients with high TMB (≥10 mut/Mb) assigned to the immunotherapy combination compared with 13% for those assigned to platinum-doublet chemotherapy. The median PFS was 7.2 months versus 5.5 months, respectively, representing a 42% reduction in risk of disease progression or death (HR, 0.58; 97.5% CI, 0.41-0.81; P <.001).”

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FDA Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC

Excerpt:

“The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC). The FDA is expected to make a decision on approval by September 5, 2018.

” ‘Our phase III results showed atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic nonsquamous non–small cell lung cancer,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech.”

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FDA Grants Genentech’s Avastin Priority Review for Certain Types of Cervical Cancer

“Genentech, a member of the Roche Group (six:RO)(six:ROG)(otcqx:RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin® (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastaticcervical [sic] cancer.

“ ‘This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients.’ ”

“The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide ‘significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.’ The sBLA for Avastin plus chemotherapy in persistent, recurrent or metastaticcervical cancer is based on data from the Phase III GOG-0240 trial with an FDA action date of October 24, 2014.”

The gist: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process. The drug Avastin (bevacizumab), already FDA-approved for several subtypes of several different cancers, was recently granted Priority Review status for the treatment of women with persistent, recurrent or metastatic cervical cancer. These patients currently only have the option of being treated with chemotherapy, but clinical trial evidence indicates that adding Avastin to the standard chemotherapy regimen might help these women live longer.