FDA Assigns Priority Review to Lenvatinib Plus Everolimus Combo in RCC
January 19th 2016The combination of lenvatinib (Lenvima) and everolimus (Afinitor) has been given a priority review status by the FDA as a treatment for patients with metastatic renal cell carcinoma (RCC) following one prior VEGF-targeted therapy.
Ipilimumab/Chemo Combo Misses OS Endpoint in Phase II Urothelial Cancer Trial
January 10th 2016The addition of the CTLA-4 inhibitor ipilimumab to cisplatin and gemcitabine failed to significantly improve the primary endpoint of overall survival (OS) in a phase II study for patients with metastatic urothelial cancer.
Hypofractionated Radiotherapy Noninferior to Standard Radiation Therapy
January 9th 2016Hypofractionated radiotherapy and standard radiation therapy demonstrated similar toxicities and neither prevented PSA increases or disease recurrences for men with intermediate-risk prostate cancer better than the other, according to data from the phase III randomized CHHiP trial reported at the 2016 GU Cancers Symposium.
FDA Approves Non-Alcohol Formulation of Docetaxel for Multiple Cancer Types
December 29th 2015The FDA has approved a new treatment consisting of a non-alcohol formulation of docetaxel in patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
New Multimodal Ovarian Cancer Screening Tactic Shows Promise
December 23rd 2015A new method of screening utilizing CA-125 and a risk assessment algorithm could drop risk of mortality from ovarian cancer in certain women, according to findings from the UK Collaborative Trial of Ovarian Cancer Screening.
European Commission Approves T-VEC for Unresectable Metastatic Melanoma
December 22nd 2015Talimogene laherparepvec (T-VEC; Imlygic) has been approved by the European Comission as a treatment for adult patients with unresectable stage IIIb, IIIc, and IVM1a melanoma that has not spread to the bone, brain, lung, or other viscera, based on the phase III OPTiM study.
Decision on Rociletinib for NSCLC Delayed by FDA
December 17th 2015The review period for rociletinib for EGFR T790M-positive non-small cell lung cancer (NSCLC) has been extended by the FDA by 3 months. The extension allows ample time to review additional data submitted by the drug's developer, Clovis Oncology.
Bortezomib Triplet Emerges as the New Standard of Care in Patients With Untreated Multiple Myeloma
December 14th 2015The SWOG S0777 trial data shows induction therapy with a triplet of bortezomib, lenalidomide, and dexamethasone improved both progression-free survival and overall survival over lenalidomide and dexamethasone alone in patients with untreated multiple myeloma.
Elotuzumab Benefits Level Out in 3-Year Myeloma Data
December 14th 2015A triplet of elotuzumab, lenalidomide, and dexamethasone produced sustained improvements in both progression-free survival and overall survival in patients with relapsed/refractory multiple myeloma, according to a 3-year analysis of the phase III ELOQUENT-2 trial.
Adjuvant Capecitabine Boosts Survival Rates in HER2-Negative Breast Cancer
December 10th 2015A combination of capecitabine and adjuvant therapy dropped the risk of recurrence by 30% and prolonged survival by 40% for patients with residual breast cancer post-neoadjuvant chemotherapy and surgery, according to phase III data.
Blinatumomab Displays Impressive CR Rates in ALL Studies
December 10th 2015Blinatumomab (Blincyto) as a single agent showed high complete remission (CR), or CR with partial hematological recovery, in adult patients with Philadelphia chromosome-positive and -negative B-cell precursor acute lymphoblastic leukemia.
FDA Approves Rapid Infusion Bendamustine for CLL and NHL
December 10th 2015A rapid infusion formulation of bendamustine (Bendeka) has received FDA approval for the treatment of patients with CLL or indolent B-cell NHL that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
Response Rates Hover Around 100% for CAR T-cell Therapies in ALL
December 8th 2015Two CD19-targeted chimeric antigen receptor (CAR)-modified T-cell therapies showed complete response (CR) rates from 90% to 100% in patients with high-risk acute lymphoblastic leukemia (ALL), according to data from two studies presented during the 2015 ASH Annual Meeting.
CAR T-Cell Therapies Produce High Response Rates in Non-Hodgkin Lymphoma
December 8th 2015Updated data shows chimeric antigen receptor (CAR)-modified T-cell therapies continue to remain effective for patients with non-Hodgkin lymphoma (NHL), according to findings presented at the 2015 ASH Annual Meeting.
Idelalisib Triplet Shows Great Efficacy in Relapsed/Refractory CLL
December 7th 2015Data from a phase III trial shows adding idelalisib to bendamustine and rituximab (BR) dropped the risk of progression and/or death by 67% when compared to BR alone in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
Daratumumab Shows Rapid and Durable Responses in Patients With Multiple Myeloma
December 6th 2015Daratumumab demonstrated a 31% overall response rate as monotherapy for patients with heavily pretreated multiple myeloma, according to a combined analysis of two pivotal studies presented at the 2015 ASH Annual Meeting.
Ixazomib, Cyclophosphamide, Dexamethasone Combination Effective in Myeloma
December 5th 2015The triple combination of ixazomib, cyclophosphamide, and dexamethasone, all taken orally, showed encouraging early response rates in elderly patients with newly diagnosed multiple myeloma, according to phase II data presented at the 2015 ASH Annual Meeting.
FDA Hands Down Complete Response Letter for Use of Nivolumab in BRAF-Mutated Melanoma
November 30th 2015The FDA has issued a complete response letter to Bristol-Myers Squibb regarding its supplemental biologics license application for the use of single-agent nivolumab in previously untreated patients with BRAF V600 mutation-positive advanced melanoma.