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Home Industry News & Regulatory Approvals

Atezolizumab Approved for Adjuvant NSCLC Therapy for Patients with Stage II-IIIA Disease, PD-L1 ≥ 1%

Joy Curzio
on: October 26, 2021In: Industry News & Regulatory Approvals
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 […] Read more


First New Second-line Therapy for SCLC in Australia in 20 Years

on: September 24, 2021In: Industry News & Regulatory Approvals
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 […] Read more

Sotorasib Scores Second-line Approval in Canada

on: September 24, 2021In: Industry News & Regulatory Approvals
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 […] Read more

Savolitinib Approved in China for MET-Positive NSCLC

on: July 30, 2021In: Industry News & Regulatory Approvals
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 […] Read more

Durvalumab Plus Chemotherapy Approved in China as First-Line Management of Extensive-stage SCLC

on: July 30, 2021In: Industry News & Regulatory Approvals
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 […] Read more

First Comprehensive Genomic Profiling Assay Approved for Use with Brigatinib, ALK-positive NSCLC

on: July 01, 2021In: Industry News & Regulatory Approvals
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 […] Read more

Selpercatinib Approved in Canada for Metastatic NSCLC with RET Fusions

on: June 15, 2021In: Industry News & Regulatory Approvals
Selpercatinib Approved in Canada for Metastatic NSCLC with RET Fusions

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 […] Read more

Sotorasib Wins Approval for Unmet Need in KRAS G12C-Driven NSCLC

on: June 01, 2021In: Industry News & Regulatory Approvals
Sotorasib Wins Approval for Unmet Need in KRAS G12C-Driven NSCLC

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 […] Read more

Tepotinib Approved for MET Exon 14 Skipping Mutated Metastatic NSCLC

on: February 08, 2021In: Industry News & Regulatory Approvals
Tepotinib Approved for MET Exon 14 Skipping Mutated Metastatic NSCLC

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, […] Read more

Osimertinib Approved as Adjuvant Therapy for NSCLC with Certain EGFR Mutations

on: December 22, 2020In: Industry News & Regulatory Approvals
Osimertinib Approved as Adjuvant Therapy for NSCLC with Certain EGFR Mutations

December 18, 2020—The U.S. Food and Drug Administration (FDA) approved osimertinib as post-resection adjuvant therapy for patients with NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, as […] Read more

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