Industry News & Regulatory Approvals

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. This was the first increase in cigarette sales in 20 years in the United States. Advertising expenditures also increased during the same time period, from…

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 patients with stage II-IIIA NSCLC and with a PD-L1 expression level of ≥ 1%. The VENTANA PD-L1 (SP263) Assay also was approved as a companion…

  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 unable to receive chemotherapy.  The National Medical Products Administration based its approval on a phase II trial of 70 patients with NSCLC that included a…

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 SCLC. This approval joins those in more than 55 countries for this indication.  The approval was based on the CASPIAN phase III trial, which demonstrated…

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 adult patients with ALK-positive NSCLC. FoundationOne CDx is a tissue-based comprehensive genomic profiling assay and is the first of this kind to receive FDA approval.…

June 15, 2021—Canada’s medical regulatory agency approved the use of selpercatinib monotherapy for treatment of patients with metastatic RET fusion–positive NSCLC. Health Canada based its conditional approval on the LIBRETTO-001 phase I/11 trial, with two phase III trials pending to confirm clinical benefit. LIBRETTO-001, a multicenter, open-label, multicohort trial, enrolled 144 patients with advanced RET…

On May 28, the US Food and Drug Administration (FDA) granted accelerated approval of sotorasib for patients with KRAS G12C-mutated NSCLC who have received at least one prior line of therapy. Previously considered an “undruggable” target, KRAS G12C is the primary driver of approximately 13% of nonsquamous NSCLC. Approval was based on the phase II…

February 3, 2021—Tepotinib was approved for treatment of patients with metastatic NSCLC who harbor MET exon 14 skipping alterations. Approval was based on data from the VISION trial (NCT02864992). VISION, a multicenter, nonrandomized, open-label, multicohort trial, enrolled 152 patients with advanced or metastatic NSCLC and MET exon 14 skipping alterations. Patients received 450 mg of…