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.
Dabrafenib/Trametinib Fully Approved by FDA for BRAF-Mutant Melanoma
November 21st 2015A combination of dabrafenib and trametinib has been approved by the FDA for patients with unresectable or metastatic BRAF-mutated melanoma, based on an extension in overall survival (OS) from two phase III studies.
Trametinib and Dabrafenib Combo Successful in Melanoma
November 19th 2015Patients receiving a combination of MEK inhibitor trametinib and BRAF inhibitor dabrafenib not only greatly improves long-term outcomes, but also lowers some adverse events associated with either standalone agent for patients with BRAF-mutated metastatic melanoma.
FDA Gives Avelumab Breakthrough Therapy Designation for Merkel Cell Carcinoma
November 18th 2015Avelumab has been given breakthrough therapy designation by the FDA as a possible treatment for patients with metastatic Merkel cell carcinoma (MCC) following progression on at least one prior chemotherapy regimen
Monoclonal Antibodies Set to Revolutionize ALL Treatment
November 5th 2015Monoclonal antibodies, specifically the CD3 and CD19 bispecific agent blinatumomab (Blincyto) and the CD22-targeted antibody-drug conjugate inotuzumab ozogamicin, are set to overhaul the treatment of adults with relapsed acute lymphoblastic leukemia.