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Home Industry News & Regulatory Approvals

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

First Therapeutic Approval in 16 years for MPM

on: October 19, 2020In: Industry News & Regulatory Approvals
First Therapeutic Approval in 16 years for MPM

October 2, 2020—As part of the U.S. Food and Drug Administration’s (FDA) Project Orbis, the FDA approved combination nivolumab and ipilimumab for treatment-naive patients with unresectable malignant plueral mesothelioma (MPM). […] Read more

FDA Perspectives on the Use of Liquid Biopsy in NSCLC

Kara Nyberg, PhD
on: October 09, 2020In: Industry News & Regulatory Approvals, Meeting News
FDA Perspectives on the Use of Liquid Biopsy in NSCLC

The US Food and Drug Administration (FDA) recognizes the value of liquid biopsy in managing patients with cancer, and the agency is actively working to bring these assays to the clinic. Harpreet Singh, MD, Director of […] Read more

Funding Opportunities for Innovative Multidisciplinary Cancer Research Teams

on: October 05, 2020In: Industry News & Regulatory Approvals
Funding Opportunities for Innovative Multidisciplinary Cancer Research Teams

The US National Cancer Institute (NCI), a division of the US National institutes of Health (NIH), is partnering with Cancer Research UK, the world’s largest independent cancer research charity, to […] Read more

FDA Approves Pralsetinib for RET Fusion–Positive NSCLC

on: October 01, 2020In: Industry News & Regulatory Approvals
FDA Approves Pralsetinib for RET Fusion–Positive NSCLC

The US Food and Drug Administration (FDA) granted Accelerated Approval to pralsetinib as treatment for adults with metastatic NSCLC who harbor RET fusions. The first and only test to identify RET fusion–positive NSCLC, the Oncomine Dx Target […] Read more

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