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News on molecular markers used to guide cancer treatment, assess prognosis, or detect relapse.
The data from the trial will support regulatory submissions in the US and EU for Libtayo as a first-line option for PD-L1 positive non-small cell lung cancer patients.
Metastatic prostate cancer patients with BRCA, PALB2, FANCA, and CDK12 mutations had an improved response than those without such mutations, a study showed.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
In the pivotal trial that led to its approval, the drug in combination with Herceptin and capecitabine showed promising activity in HER2-positive, breast cancer patients with brain metastasis.
Affimed announced the first patient dosed in a Phase I/IIb trial of AFM24, designed to bind CD16A receptors on innate immune cells and EGFR receptors on tumor cells.
This is the second approval for tislelizumab following the drug's initial approval in classical Hodgkin's lymphoma last year.
Encorafenib (Pfizer/Array BioPharma's Braftovi) is approved in combination with cetuximab (Eli Lilly's Erbitux) for previously treated patients.
Oncolytics will run two biomarker validation studies before pursuing the first registration enabling trial in HR-positive, HER2-negative breast cancer for Reolysin.
A case series in partnership with My Gene Counsel to highlight the challenges genetics professionals and oncologists are grappling with as genetic testing is increasingly used in patient care.
The approval presents another treatment option for the 3 percent to 5 percent of metastatic NSCLC patients with ALK rearrangements.