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The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing.
Bristol Myers Squibb is hoping that the durable responses seen with the combined immunotherapy drugs will convince doctors to prescribe it for their patients.
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The latest approval is immunotherapy Tecentriq's fourth indication in non-small cell lung cancer and fifth indication in lung cancer.
The agency granted breakthrough therapy designation to the antibody-drug conjugate based on data from the ongoing Phase II DESTINY-Lung01 trial.
Clinicians will be able to use the assay to help identify patients with metastatic NSCLC for treatment with nivolumab and ipilimumab.
This approval, based on the part 1a results from the Phase III CheckMate-227 trial, is the fifth indication for this drug combination.
The accelerated approval was based on data from the TRITON2 trial involving metastatic patients with BRCA mutations and homologous recombination deficiency.
The firms are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2 and NTRK3, for Bayer's Vitrakvi cancer treatment.
The guideline, in effect for three months, gives access to many molecularly informed indications that NICE previously found not cost-effective or that it hasn't yet reviewed.
The company will now initiate the dose escalation portion of a Phase I/II study and will enroll 90 NSCLC patients in the country.
The accelerated approval was granted based on data submitted from the Phase I/II LIBRETTO-001 trial.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
The firm can now market the drug to Chinese patients with early-stage HER2-positive breast cancer.
The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
Under this agreement, Bixink will be responsible for seeking regulatory approval for Nerlynx in South Korea, and Puma could receive payments of up to $6 million from drug sales.
The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.
WUSTL will evaluate BostonGene's software, which integrates data from NGS with immunofluorescence imaging to profile tumors and their microenvironments.
Under the deal, the companies aim to develop a companion diagnostic for Bayer's solid tumor drug larotrectinib for the Chinese market.
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.