Industry News & Regulatory Approvals
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Regulatory News for February 23, 2022
Taiwan OKs nivolumab IV infusion in some cases. UK approves atezolizumab for NSCLC. European Commission greenlights lorlatinib for advanced ALK-positive disease.
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Regulatory News for February 9, 2022
Sotorasib earns approval in European Union, Japan. Scotland OKs osimertinib.
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New Warranty, Rebate Programs Put Spotlight on Value in Lung Cancer
Value-based care is getting more attention in lung cancer thanks to two new programs offering significant rebates or full refunds should the therapeutic agent be ineffective or intolerable. Pfizer’s pilot […]
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Cigarette Sales Up in U.S. for the First Time in 20 Years
October 26, 2021—The U.S. Federal Trade Commission’s (FTC’s) recently released Cigarette Report1 showed that the number of cigarettes sold increased from 202.9 billion in 2019 to 203.7 billion in 2020. […]
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Atezolizumab Approved for Adjuvant NSCLC Therapy for Patients with Stage II-IIIA Disease, PD-L1 ≥ 1%
October 15, 2021— Based on the results of phase III IMpower010, atezolizumab was approved by the U.S. Food and Drug Administration (FDA) as adjuvant treatment after surgery and chemotherapy for […]
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First New Second-line Therapy for SCLC in Australia in 20 Years
SEPTEMBER 14, 2021—Lurbinectedin received approval from the Therapeutic Goods Administration (TGA) as treatment for patients with metastatic SCLC who experienced disease progression during or after receipt of platinum-based chemotherapy. The […]
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Sotorasib Scores Second-line Approval in Canada
SEPTEMBER 14, 2021—Health Canada approved sotorasib for second-line treatment of patients with locally advanced or metastatic NSCLC and a KRAS G12C mutation. A Notice of Compliance with Conditions was granted […]
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Savolitinib Approved in China for MET-Positive NSCLC
June 23, 2021—Savolitinib was approved in China for treatment of patients with NSCLC with MET exon 14 skipping alterations whose disease has progressed following systemic treatment or who are […]
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Durvalumab Plus Chemotherapy Approved in China as First-Line Management of Extensive-stage SCLC
July 19—The National Medical Products Administration in China approved durvalumab in combination with standard-of-care platinum chemotherapy (as defined as etoposide plus carboplatin or cisplatin) for the first-line management of extensive-stage […]
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First Comprehensive Genomic Profiling Assay Approved for Use with Brigatinib, ALK-positive NSCLC
July 1, 2021—The U.S. Food and Drug Administration (FDA) has approved FoundationOne CDx for use as a companion diagnostic for brigatinib, which the FDA had previously approved for treatment of […]
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