Cancer Drugs Granted Breakthrough Therapy Designation in China

s Investigational TAR-200 Granted US FDA Breakthrough Therapy ...

Breakthrough Therapy Designation for Novel Targeted ... Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer.

Breakthrough Therapy Designation: - DGRA

Moreover, the top oncology indications in which BTD drugs have been approved include non-small cell lung cancer (NSCLC). (25%), multiple myeloma (MM) (17 ...

Dizal's Sunvozertinib Approved by China NMPA ... - NEWS DETAIL

... Drug in China for the treatment of lung cancer that has been granted breakthrough therapy designations from both the NMPA and the FDA.

HUTCHMED Receives Breakthrough Therapy Designation in China

HUTCHMED Receives Breakthrough Therapy Designation in China for Fruquintinib Combination with Sintilimab for Treatment of Advanced Endometrial ...

IMFINZI® (durvalumab) granted Priority Review and Breakthrough ...

IMFINZI® (durvalumab) granted Priority Review and Breakthrough Therapy Designation for patients with limited-stage small cell lung cancer in the ...

Hutchmed China Ltd - Breakthrough Therapy Designation for ...

Favorable results from this trial could lead to submission to the NMPA in the first half of 2024 for regulatory approval in this treatment setting. About ...

Pfizer's XALKORI® (crizotinib) Receives FDA Breakthrough Therapy ...

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for ...

HUTCHMED Receives Breakthrough Therapy Designation in China ...

HUTCHMED Receives Breakthrough Therapy Designation in China for Fruquintinib Combination with Sintilimab for Treatment of Advanced Endometrial ...

Review time of oncology drugs and its underlying factors - Frontiers

Clinical trial evidence supporting FDA approval of drugs granted breakthrough therapy designation. ... Newly approved cancer drugs in China ...

GSK5764227 Receives Breakthrough Therapy Designation for ...

Breakthrough therapy designation has been granted by the FDA to the B7-H3–targeted antibody-drug conjugate (ADC), GSK5764227 (HS-20093), to treat extensive- ...

Press Release Details - Deciphera Pharmaceuticals, Inc.

In October 2019 , FDA granted Breakthrough Therapy Designation (BTD) for ripretinib for the treatment of patients with advanced GIST who have ...

Breaking News | Virogin's First Oncolytic Virus VG161 Receives ...

It has officially been included in the list of breakthrough therapies for the treatment of patients with advanced hepatocellular carcinoma (HCC) who have ...

Novartis receives FDA Breakthrough Therapy designation for ...

Novartis announced that the FDA has granted Breakthrough Therapy designation to Scemblix® (asciminib) for the treatment of adult patients with newly diagnosed ...

Characteristics of expedited programmes for cancer drug approval ...

Breakthrough Therapy (BT) Designation took effect in. July 2020, and there ... cancer drugs approved in China between 2016 and 2020. Total development ...

FDA Grants Breakthrough Therapy Designation to Sotorasib for ...

The FDA granted breakthrough therapy designation to sotorasib for the treatment ... cancer had progressed despite prior treatment with ...

Zanidatamab Granted Priority Review for HER2-Positive Metastatic ...

Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China. About Biliary Tract Cancer BTC ...

HUTCHMED Receives Breakthrough Therapy Designation in China ...

HUTCHMED (China) Limited recently announced the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) has granted.

Bayer wins FDA breakthrough therapy designation for NSCLC ...

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Bayer for its non-small cell lung cancer (NSCLC) candidate BAY ...

Sunvozertinib Granted Breakthrough Therapy Designation by China ...

Sunvozertinib Granted Breakthrough Therapy Designation by China CDE for the First-Line Treatment of Non-Small Cell Lung Cancer with EGFR Exon 20 ...

Press Release - AnHeart Therapeutics

In 2022, taletrectinib was granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of adult patients with ...