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More articles about Regulatory News & FDA Approvals

This is the second precision oncology drug approved by the agency for patients with RET-mutant medullary thyroid cancer or RET fusion-positive thyroid cancer.

The company has begun a Phase III trial of infigratinib as a first-line treatment for FGFR2 fusion-positive cholangiocarcinoma.

The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.

The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo.

The agency recommended the combination for previously untreated CLL patients with certain genetic mutations, including those with a 17p deletion or TP53 mutation.

The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.

The combination treatment was approved for metastatic NSCLC patients without EGFR or ALK gene mutations and regardless of their PD-L1 status.

Regulators approved the PARP inhibitor as a monotherapy for BRCA1/2-mutated mCRPC and together with Avastin for advanced, HRD-positive ovarian cancer.

Though Guardant and Foundation have pioneered a path through the FDA for liquid biopsy tests, label differences highlight complex choices for oncologists.

Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.

The FDA also granted priority review for Enhertu for the treatment of patients with HER2-positive metastatic gastric cancer.

FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer.

The test analyzes substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, along with some genomic signatures in solid tumors.

Although pandemic-related manufacturing delays impacted the NDA filing, the company remains on track to file its PMA for the companion diagnostic by year end.

The agency made the recommendation based on data showing that Keytruda improved outcomes and was cost-effective compared to the standard treatment.

The company submitted data from the ADAURA study, and the agency is slated to issue a decision on the application by the first quarter in 2021.

The decision comes after EMA's CHMP determined that the submitted evidence was not strong enough to demonstrate the drug's benefit in this setting.

With the FDA's acceptance of its IND application for the drug, the Boston-headquartered firm will begin studying it in TP53-mutated MDS patients.

In Europe, Blueprint will commercialize the drug first in Germany as a treatment for advanced GIST patients with a PDGFRA D842V mutation.

The company will seek FDA approval in advanced systemic mastocytosis, a disorder that can turn into cancer in 7 percent of children and 30 percent of adults.

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