FDA Approves Two Sickle Cell Gene Therapies Including First CRISPR Drug
The FDA approved a gene-editing drug from Vertex Pharmaceuticals and CRISPR Therapeutics and a gene therapy from Bluebird Bio.
SABCS Studies Explore Germline Mutations' Varied Effects on Breast Cancer Risk, Survival Outcomes
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Researchers examine the interplay of germline cancer risk mutations and somatic mutations, and how surgery type and contraceptives impact breast cancer risk.
Tukysa-Kadcyla Combo Shows Efficacy in HER2-Positive Breast Cancer Patients With Brain Metastases
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Researchers at SABCS said data from HER2CLIMB-02 could influence imaging and treatment strategies for patients whose breast cancer has spread to the brain.
Dato-DXd Phase III Data Shows Promising Efficacy, Safety Profile in Competitive Breast Cancer Market
At SABCS, researchers shared updated data on the Trop2 antibody-drug conjugate in advanced HR-positive, HER2-low or -negative breast cancer, and said biomarker analysis is forthcoming.
Chemo-Free Regimens for Hormone Receptor, HER2-Positive Breast Cancer Show Promise at SABCS
Researchers shared data from two single-arm trials, in which the combination of anti-HER2 treatment, a CDK4/6 inhibitor, and hormone therapy benefitted patients with aggressive disease.
Ovarian Cancer Detected Early With DNA From Pap Smear in Proof-of-Principle Study
Researchers developed an early ovarian cancer test based on DNA from Pap smears from women who went on to develop high-grade serous ovarian cancer.
FDA Publishes Letter to Novartis Detailing Kymriah Manufacturing Safety Concerns
In the letter, which the agency sent to Novartis in August, FDA inspectors referenced contaminated batches of the cell therapy product and moldy facilities.