Roche’s Tecentriq Receives the US FDA’s Approval as 1L Monotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

 Roche’s Tecentriq Receives the US FDA’s Approval as 1L Monotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

Roche’s Tecentriq Receives the US FDA’s Approval as 1L Monotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

Shots:

  • The US FDA has approved Tecentriq (atezolizumab) as a 1L Treatment for adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells or PD-L1 stained tumor-infiltrating covering ≥ 10% of the tumor area), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
  • The approval is based on an interim analysis from the Phase III IMpower110 study assessing Tecentriq as monothx. vs cisplatin/ carboplatin and pemetrexed/ gemcitabine (CT) in 572 PD-L1-selected, CT-naïve participants in ratio (1:1) with stage IV non-sq. or sq. NSCLC
  • The P-III IMpower110 study results: improvement in OS by 7.1mos. median OS (20.2 vs 13.1 mos.); safety is consistent with the known safety profile; no new safety profile was identified. The approval marks Tecentriq’s fourth indication in mNSCLC and fifth indication in lung cancer in the US

Click here to­ read full press release/ article | Ref: Roche  | Image: NY Daily News

Related News:    Roche Reports the US FDA Acceptance of sBLA and Granted Priority Review for Tecentriq (atezolizumab) as 1L Monotherapy for Advanced Non-Small Cell Lung Cancer

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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