Avelumab Demonstrates Durable Activity in Merkel Cell Carcinoma
April 5th 2017According to results of the phase II JAVELIN Merkel 200 study, the PD-L1 inhibitor avelumab (Bavencio) induced an objective response rate (ORR) of 33% in patients with advanced Merkel cell carcinoma, including 2 additional complete responses (CR) since the primary analysis.
sBLA for Full Approval of Blinatumomab in ALL Granted FDA's Priority Review
March 30th 2017The FDA has granted a priority review to a supplemental biologics license application (sBLA) supporting the conversion of the accelerated approval of blinatumomab (Blincyto) to a full approval as a treatment for patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
Niraparib Approved by FDA for Ovarian Cancer
March 27th 2017The PARP inhibitor niraparib (Zejula) has been approved by the FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
EMA Recommends Nivolumab for Approval in Head and Neck Cancer
March 24th 2017Nivolumab (Opdivo) has been recommended for approval by EMA’s Committee for Medicinal Products for Human Use for the treatment of patients with squamous cell cancer of the head and neck following progression on platinum-based therapy.
Ribociclib Approved by FDA for Frontline HR+/HER2- Breast Cancer
March 14th 2017The CDK 4/6 inhibitor ribociclib has been approved by the FDA for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor–positive, HER2-negative advanced breast cancer.
PARP Inhibitors Likely This Year's Breakthrough In Breast Cancer Management
March 12th 2017Kimberly Blackwell, MD, discusses the results of the recent phase III OLYMPIAD trial, which showed olaparib (Lynparza) improved progression-free survival (PFS) versus standard chemotherapy in patients with <em>BRCA</em>-positive breast cancer.
Ribociclib Results Promising for Elderly Patients With HR+/HER2- Breast Cancer
March 10th 2017The addition of the CDK4/6 inhibitor ribociclib to frontline letrozole reduced the risk of disease progression or death by 40% in elderly patients with hormone receptor-positive, HER2-negative advanced breast cancer.
Pembrolizumab Granted Priority Review in Second-Line Bladder Cancer
February 4th 2017A supplemental Biologics License Application for pembrolizumab has been granted a priority review by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who progress following platinum-containing chemotherapy.
Maintenance Lenalidomide Recommended for Approval in Post-ASCT Myeloma by CHMP
January 30th 2017Based on data from 2 phase III trials, the EMA’s CHMP has recommended approval of lenalidomide as a maintenance therapy following autologous stem cell transplant for patients with newly diagnosed multiple myeloma.
Esophageal Cancer Outcomes Improved by PET-Guided Treatment
January 20th 2017Pathologic complete response (pCR) rates were improved by switching neoadjuvant chemotherapy regimens based on PET imaging after induction chemotherapy in patients with esophageal and gastroesophageal junction (GEJ) cancers, according to findings from the phase II CALGB 80803 study.