Precision Oncology Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Roche's Tecentriq Nabs EC Approval in Triple-Negative Breast Cancer, Ventana Expands Use of CDx

The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.

New FDA Program May Help Oncologists Access Investigational Drugs in Precision Medicine Era

The program, called Project Facilitate, aims to help oncologists request access to investigational drugs but may only simplify part of the process.

Genentech's Rozlytrek Garners FDA Approval in NTRK-Positive Cancers for Adults, Adolescents

This is the third drug the agency has approved with a pan-cancer indication.

Guardant Health Preps Pan-Cancer FDA Bid, Highlights New MSI Validation Data

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The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.

Myriad Genetics Seeking Additional FDA Approval for BRACAnalysis CDx

The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.

Aug 01, 2019

FDA Approves Expanded Use of Agilent CDx for Keytruda in Esophageal Cancer

Jul 23, 2019

China's NMPA Extends Approval for Roche Cobas EGFR Mutation Test v2 to Plasma Samples

Jul 01, 2019

FDA Approves Foundation Medicine CDx Test for Lynparza

Jun 27, 2019

Japanese Regulator Approves Foundation Medicine CDx Assay for Roche's Rozlytrek

Jun 21, 2019

Patients, Advocates Urge FDA to Expedite Approval of ONC201 for Rare, Mutation-Defined Gliomas

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Jun 21, 2019

Liquid Biopsy Assay From MSKCC Approved by New York State

Jun 19, 2019

Japanese Regulators Approve Invivoscribe Assay as CDx for Daiichi Sankyo AML Drug

Jun 19, 2019

AstraZeneca, Merck's Lynparza, Myriad Genetics' BRCA Test Approved in Japan

Jun 18, 2019

Roche's Rozlytrek Nets Japanese Approval in NTRK-Positive Pan Cancer Indication

Jun 18, 2019

European Commission Approves Lynparza for Advanced Ovarian Cancer With BRCA Mutations

Jun 11, 2019

FDA Approves Expanded Use of Agilent CDx for Keytruda in Head and Neck Cancer

May 24, 2019

FDA Approves Novartis' Piqray for PIK3CA-Mutated Advanced Breast Cancer

May 13, 2019

Transgene Moves Ahead With Phase I Study of First Individualized Ovarian Cancer Immunotherapy

May 06, 2019

FDA Grants IDE Approval for Almac Diagnostic Services' CDx for Use in Cancer Drug Study

Apr 17, 2019

FDA Approves Expanded Use of Agilent CDx for Keytruda in Lung Cancer

Apr 12, 2019

FDA Approves Qiagen Companion Dx for Bladder Cancer Drug Balversa

Apr 09, 2019

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