Noted This Week

October 12–18

The FDA approved the PARP inhibitor talazoparib (Talzenna; Pfizer) for patients with advanced or metastatic HER2-negative breast cancer who have BRCA1/2 mutations. The approval was based on results of the phase III EMBRACA trial, in which patients treated with the drug had a median progression-free survival of 8.6 months, compared with 5.6 months in patients who received chemotherapy. The agency also approved the BRACAnalysis CDx test (Myriad Genetics) as a companion diagnostic.

The agency also issued a draft guidance on the use of minimal residual disease (MRD) as a biomarker in clinical trials for blood cancers. The document outlines how MRD might be used in trials, considerations for specific hematologic malignancies, and requirements for drug applications that utilize MRD. The FDA will release a final guidance after addressing any concerns raised during the current 60-day comment period.

Researchers released molecular data from 562 patients with acute myeloid leukemia (AML), reporting their initial findings in Nature. The data, gathered in the Beat AML Master Trial and available to researchers online, includes genomic sequencing results from 672 tumors, as well as assessments of how tumor cells responded to targeted therapies.

Novartis will acquire Endocyte, which develops radiopharmaceuticals, for $2.1 billion. Endocyte’s lead candidate is Lu-PSMA-617, a radioligand being studied in a phase III trial of men with metastatic castration-resistant prostate cancer.

Genomic testing of pediatric patients with cancer can provide clinically useful information, according to findings from the Genomes for Kids study presented at the American Society of Human Genetics 2018 Annual Meeting in San Diego, CA. Researchers sequenced tumors and non-cancerous tissues from 253 patients across cancer types, and determined that 79% of the time, at least one finding could help guide care by providing a diagnosis, revealing patient-specific risks, or identifying drug targets.

Bristol-Myers Squibb announced that in the phase III CheckMate-331 trial, the PD-1 inhibitor nivolumab (Opdivo) did not extend overall survival in patients with small cell lung cancer (SCLC) who relapsed after chemotherapy. The FDA previously granted the drug an accelerated approval for patients with SCLC who have received chemotherapy and at least one other therapy.

Most women diagnosed with ovarian cancer worldwide are unfamiliar with the disease, according to results of the World Ovarian Cancer Coalition Every Woman Study. Researchers surveyed over 1,500 women with ovarian cancer in 44 countries, and found that two thirds had minimal knowledge of the disease before diagnosis, and while nine in ten experienced symptoms prior to diagnosis, less than half consulted a doctor within a month.


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