The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
FDA Panel to Review Olaparib Application in Metastatic Pancreatic Cancer
December 6th 2019The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for December 17, 2019, to discuss a supplemental new drug application for olaparib tablets as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.
Olaparib Approved in China for Frontline Maintenance in Ovarian Cancer
December 5th 2019China’s National Medical Products Administration has granted marketing authorization for olaparib as a first-line maintenance treatment for adult patients with newly diagnosed advanced germline or somatic BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy.
Germline Variants Provide Insight Into Tumor Growth in Prostate Cancer
December 5th 2019Select DNA variants leading to methylation dysregulation within the germline DNA of men with localized prostate cancer were found to be predictive of disease biology, suggesting the prognostic capacity of inherited elements of a patient’s genome, according to data published in Nature Medicine.
FDA Grants Abatacept Breakthrough Designation for Acute GVHD
December 5th 2019The FDA has granted a breakthrough therapy designation for abatacept for the prevention of moderate-to-severe acute graft-versus-host disease in patients who have undergone hematopoietic stem cell transplants from unrelated donors.
FDA Approves Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel for Nonsquamous NSCLC
December 4th 2019The FDA has approved atezolizumab in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer who do not harbor EGFR or ALK molecular aberrations.
Sacituzumab Govitecan TNBC Application Resubmitted to FDA
December 4th 2019Immunomedics has resubmitted its biologics license application to the FDA for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease.
Trastuzumab Biosimilar Ogivri Launches in United States
December 3rd 2019The trastuzumab biosimilar Ogivri (MYL-1401O; trastuzumab-dkst) has been launched in the United States for all indications of the reference product, including the treatment of patients with HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.
UK Expands Olaparib Maintenance Indication in Ovarian Cancer
December 3rd 2019The UK’s National Institute for Health and Care Excellence has approved olaparib for the maintenance treatment of adult patients with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease responded to platinum-based chemotherapy and harbor BRCA1/2 mutations.
FDA Schedules ODAC Meeting on Tazemetostat for Epithelioid Sarcoma
December 3rd 2019The FDA has scheduled an Oncology Drugs Advisory Committee hearing for December 18, 2019, to discuss data supporting a new drug application for tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery.
NICE Approves Palbociclib Combo for HR+ Advanced Breast Cancer
December 3rd 2019The UK National Institute for Health and Care Excellence has approved palbociclib in combination with fulvestrant for the treatment of female patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy.
FDA Grants Pembrolizumab Priority Review for High-Risk NMIBC
December 2nd 2019The FDA has granted a priority review designation to pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.
Enzalutamide Gains Approval in China for mCRPC
November 28th 2019China’s National Medical Products Administration has granted approval to enzalutamide for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic following progression on androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
FDA Grants Priority Review to Pemigatinib for FGFR2+ Cholangiocarcinoma
November 27th 2019The FDA has granted a priority review to a new drug application for pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.