Burning Rock Biotech's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Burning Rock Biotech (BNR).
Over the past two years, Burning Rock Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Capivasertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Capivasertib FDA Regulatory Events
Capivasertib is a drug developed by Burning Rock Biotech for the following indication: in Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Capivasertib
- Announced Date:
- September 24, 2025
- Indication:
- in Breast Cancer
Announcement
Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca's capivasertib has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW).
AI Summary
Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that their OncoGuide™ OncoScreen™ Plus CDx System has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare. This new companion diagnostic will guide the use of AstraZeneca’s capivasertib in combination with fulvestrant.
The CDx System uses next-generation sequencing to detect PIK3CA, AKT1, and PTEN gene changes from tumor tissue in a single test. It is designed for adult patients with unresectable or recurrent hormone-receptor-positive, HER2-negative breast cancer whose disease has progressed after endocrine therapy.
By helping doctors select patients whose tumors carry relevant genetic alterations, this tool aims to improve treatment decisions and patient outcomes. Riken Genesis will work on securing insurance coverage to ensure timely access across Japan.
Both companies plan to expand registration efforts in other markets, seeking broader patient benefits from this precision diagnostic technology.
Read Announcement
Burning Rock Biotech FDA Events - Frequently Asked Questions
As of now, Burning Rock Biotech (BNR) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Burning Rock Biotech (BNR) has reported FDA regulatory activity for Capivasertib.
The most recent FDA-related event for Burning Rock Biotech occurred on September 24, 2025, involving Capivasertib. The update was categorized as "Approved," with the company reporting: "Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca's capivasertib has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW)."
Currently, Burning Rock Biotech has one therapy (Capivasertib) targeting the following condition: in Breast Cancer.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:BNR) was last updated on 9/26/2025 by MarketBeat.com Staff
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