Oncology

AstraZeneca’s Imfinzi Plus Tremelimumab Fails to Meet Primary Endpoint in Phase 3 Trial

The Phase III DANUBE trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy for Imfinzi monotherapy in patients whose tumour cells and/or tumour-infiltrating immune cells express high levels (≥25%) of PD-L1, or for Imfinzi plus tremelimumab in …

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TG Therapeutics’ Umbralisib Receives Orphan Drug Designation from the FDA for Treatment of Follicular Lymphoma

NEW YORK, March 05, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to umbralisib, the Company’s investigational dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of patients with follicular lymphoma (FL). Umbralisib is being evaluated across several …

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Report Finds that Colorectal Cancer Burden is Shifting to Younger Individuals

March 5, 2020—ATLANTA— The burden of colorectal cancer is swiftly shifting to younger individuals as incidence increases in young adults and declines in older age groups, according to Colorectal Cancer Statistics 2020, a publication of the American Cancer Society. A sign of the shift: the median age of diagnosis has dropped …

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FDA Grants Breakthrough Device Designation for Roche’s Elecsys GALAD Score to Support Earlier Diagnosis of Hepatocellular Carcinoma

Basel, 4 March 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys® GALAD score.* This algorithmic score combines gender and age with the biomarker results of the Elecsys AFP, AFP-L3 and PIVKA-II and …

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FDA Approves Sarclisa for Treatment of Patients with Relapsed Refractory Multiple Myeloma

PARIS – March 2, 2020 – The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected …

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Proscia and UCSF Partner to Deliver Artificial Intelligence Applications That Improve the Accuracy and Speed of Cancer Diagnosis

PHILADELPHIA & SAN FRANCISCO–(BUSINESS WIRE)–Proscia, a leading provider of artificial intelligence (AI) enabled digital pathology solutions, and the University of California, San Francisco (UCSF) have partnered to introduce artificial intelligence into the practice of pathology. Beginning with prostate cancer, the second leading cause of cancer deaths among men in the …

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Gilead to Acquire Immuno-Oncology Company Forty Seven for $4.9 Billion

FOSTER CITY, Calif. & MENLO PARK, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Forty Seven, Inc. (Nasdaq: FTSV) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Forty Seven for $95.50 per share in cash. The transaction, which values Forty Seven at …

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Merck’s Keytruda Significantly Improved PFS with Brentuximab Vedotin in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-204 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) met one of its dual primary endpoints of progression-free …

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FDA Grants Priority Review to MorphoSys’ BLA for Tafasitamab and Lenalidomide for Treatment of Relapsed/Refractory DLBCL

MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) announced today that the U.S. Food and Drug Administration (FDA) accepted filing of MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab, the Company’s investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment …

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Phase 3 Study of AbbVie’s Venclexta in Combination with Low-Dose Cytarabine Fails to Meet Primary Endpoint in Patients with Newly-Diagnosed AML

NORTH CHICAGO, Ill., Feb. 28, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the VIALE-C (M16-043) trial of venetoclax (VENCLEXTA®) in combination with low-dose cytarabine (LDAC) versus LDAC in combination with placebo did not meet its primary endpoint of statistically significant improvement of overall survival (OS) for …

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