Umbralisib Granted Orphan Drug Status for Follicular Lymphoma
March 7th 2020The FDA has granted an orphan drug designation to umbralisib for the treatment of patients with follicular lymphoma, according to TG Therapeutics, Inc, the developer of the dual inhibitor of PI3K-delta and CK1-epsilon.
Individualized Treatment Is Key for mCRC
March 5th 2020Key elements that should inform treatment decisions for patients with metastatic colorectal cancer (mCRC) include molecular profiling, tumor sidedness, and microsatellite instability–high (MSI-H)/mismatch repair deficient (dMMR) status, according to Michael J. Overman, MD.
Antidepressant May Improve Prostate Cancer Outcomes
March 4th 2020The antidepressant phenelzine showed antitumor activity in patients with biochemical recurrent castrate-sensitive prostate cancer, according to a pilot study conducted by researchers at the University of Southern California (USC).
FDA Approves Isatuximab-irfc for Previously Treated Myeloma
March 3rd 2020The Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) plus pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who had 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.
FDA Grants Priority Review to Tafasitamab/Lenalidomide Combination for DLBCL
March 2nd 2020The FDA granted priority review to a biologics license application for tafasitamab in combination with lenalidomide for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
Laparoscopic Power Morcellators for Gynecologic Surgery: FDA Releases Safety Statement
March 2nd 2020In an effort to make the use of laparoscopic power morcellators (LPMs) a safer and more effective choice in gynecologic surgeries, the FDA has released a statement that it will be putting a handful of strategies and recommendations in place
More Work Needed to Determine Best Treatment for High-Risk Myeloma
February 29th 2020Autologous stem cell transplantation continues to have a significant role for patients with high-risk myeloma; however, research efforts continue to focus on novel induction, consolidation, and maintenance regimens, as well as the use of tandem transplant, explained Andrew Branagan, MD.
FDA ODAC Votes on Safety and Efficacy of Ramucirumab Plus Erlotinib for EGFR+ NSCLC
February 27th 2020The FDA Oncologic Drugs Advisory Committee voted 6 to 5 that ramucirumab plus erlotinib demonstrated a favorable benefit and risk profile for patients with untreated metastatic EGFR-positive non-small cell lung cancer.
FDA Approves Neratinib Combination for HER2+ Breast Cancer
February 26th 2020The FDA has approved a supplemental new drug application (sNDA) for neratinib (Nerlynx) in combination with capecitabine (Xeloda) for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.
FDA Accepts BLA for Pertuzumab/Trastuzumab Combo for HER2+ Breast Cancer
February 26th 2020The FDA has accepted a Biologics License Application (BLA) for a fixed-dose combination (FDC) of pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.
FDA Accepts Niraparib Application for Frontline Maintenance Ovarian Cancer Treatment
February 25th 2020The FDA has accepted a supplemental New Drug Application (sNDA) for niraparib (Zejula) for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.
Personalized Treatments, HER2-Directed Drugs Are Changing the Breast Cancer Space
February 23rd 2020The fields of early-stage hormone receptor (HR)–positive and metastatic HER2-positive breast cancer have made great strides in recent years, said Neelima Denduluri, MD, and such progress could be attributed to the emergence of tailored treatment strategies and the use of HER2-directed agents, respectively.
FDA Grants Priority Review to Selinexor for DLBCL Treatment
February 21st 2020The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for selinexor (Xpovio) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, who have received ≥2 prior therapies.