Epacadostat Added to Pembrolizumab is a Promising Combination in Bladder Cancer
June 6th 2017When epacadostat, an IDO1 inhibitor, was combined with pembrolizumab (Keytruda), a PD-1 inhibitor, responses were seen in 35% of patients with advanced urothelial carcinoma, according to findings presented during the 2017 ASCO Annual Meeting.
Abemaciclib Added to Fulvestrant Improves Response in HR+/HER2- Breast Cancer
June 4th 2017The risk of disease progression or death was reduced by 45% with the addition of abemaciclib to fulvestrant compared with that of fulvestrant alone in patients with previously treated HR-positive/HER2-negative breast cancer, according to findings presented during the 2017 ASCO Annual Meeting.
Adjuvant Sunitinib Receives FDA's Priority Review Designation for High-Risk RCC
June 1st 2017Sunitinib (Sutent) has been granted a priority review designation by the FDA for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.
Neratinib Receives FDA Panel Support for Approval in HER2-Positive Breast Cancer
May 24th 2017Neratinib has been recommended for approval by the FDA’s Oncologic Drugs Advisory Committee in a 12-4 vote for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab.
Benefit of Encorafenib/Binimetinib Combo in Melanoma Confirmed in Updated Findings
May 11th 2017The BRAF inhibitor encorafenib combined with the MEK inhibitor binimetinib reduced the risk of disease progression or death by 23% compared with single-agent encorafenib for patients with <em>BRAF</em>-mutant melanoma.
Frontline Pembrolizumab Combo Approved by FDA for NSCLC
May 11th 2017Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for use in combination with pemetrexed plus carboplatin as a frontline treatment for patients with metastatic or advanced nonsquamous non–small cell lung cancer, regardless of PD-L1 expression.
Midostaurin Approved by FDA for AML
April 28th 2017Midostaurin (Rydapt) has been approved by the FDA for the treatment of adult patients with newly diagnosed <em>FLT3</em>-positive acute myeloid leukemia (AML) in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
CTL019 Granted Breakthrough Designation by FDA for DLBCL
April 18th 2017Tisagenlecleucel-T has been granted a breakthrough therapy designation by the FDA for use as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma after the failure of at least 2 prior therapies.
ODAC Meeting Scheduled by FDA for Neratinib in HER2+ Breast Cancer
April 18th 2017An Oncologic Drugs Advisory Committee hearing has been scheduled by the FDA for May 24, 2017, to discuss a new drug application for neratinib as a treatment for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab.
Alectinib Superior to Crizotonib for Frontline ALK+ NSCLC in Phase III ALEX Trial
April 10th 2017According to findings from the phase III ALEX trial, alectinib reduced the risk of disease progression or death compared with crizotinib as a frontline treatment for patients with <em>ALK</em>-positive non–small cell lung cancer.