Atezolizumab Shows Tumor Reduction for Bladder Cancer in the Second Line
July 22nd 2015The anti-PDL1 agent, atezolizumab (MPDL3280A) may effectively shrink tumors in patients with locally advanced or metastatic urothelial bladder cancer in the second-line setting, according to a statement from the immunotherapy’s developer, Genentech.
European Commission Approves Nivolumab for Patients with Squamous NSCLC
July 21st 2015Nivolumab (Opdivo) was recently approved by the European Commission as a treatment for patients who have locally advanced or metastatic squamous non-small cell lung cancer (NSCLC), following prior chemotherapy, based on findings from the phase III Checkmate-017, as well as the phase II Checkmate-063 trials.
PIK3CA/PTEN Linked to Extended PFS in Patients With HER2-Positive Breast Cancer
July 21st 2015A recent combined analysis of the BOLERO-1 and -3 studies showed that PIK3CA mutations and low/no expression of PTEN linked to an extension in progression-free survival (PFS) for patients who have metastatic HER2-positive breast cancer and are treated with a combination of everolimus, trastuzumab, and paclitaxel.
Cabozantinib (Cometriq) Improves PFS and OS in Patients With mRCC
July 20th 2015Results from the phase III METEOR study showed that treatment with cabozantinib (Cometriq) improved progression-free survival (PFS) and overall survival (OS) compared with everolimus (Afinitor) in previously treated patients with metastatic renal cell carcinoma (mRCC).
Efficacy of Blinatumomab Presented in Phase II Ph+ ALL Study
July 20th 2015According to findings from a phase II study released by Amgen, monotherapy with blinatumomab (Blincyto) showed promising complete remission (CR) or CR with partial hematological recovery (CRh) rates in adult patients with relapsed or refractory Philadelphia chromosome-positive (Ph+) B cell precursor acute lymphoblastic leukemia (ALL).
FDA to Review Ixazomib in Relapsed and/or Refractory Multiple Myeloma
July 16th 2015Takeda released a statement saying that a new drug application was submitted for ixazomib (MLN9708), an oral proteasome inhibitor, used in combination with lenalidomide and dexamethasone, as a treatment for patients with relapsed and/or refractory multiple myeloma.
Necitumumab for Patients With Squamous NSCLC Supported by ODAC
July 10th 2015The approval of necitumumab, combined with gemcitabine and cisplatin for the first-line treatment of patients who have locally advanced or metastatic squamous non-small cell lung cancer (NSCLC), was supported by FDA’s Oncologic Drugs Advisory Committee (ODAC).
Colorectal Tumors Deficient in Mismatch Repair Respond to PD-1 Inhibition
June 5th 2015Patients with heavily pretreated colorectal cancer who harbored genetic defects in mismatch repair experienced high response rates when treated with the programmed cell death protein-1 inhibitor pembrolizumab (Keytruda), according to findings from an ongoing phase II study.
PD-1/PD-L1 Inhibitors Show Safety and Efficacy in Advanced Ovarian Cancer
June 5th 2015Patients with pretreated advanced ovarian cancer demonstrated encouraging signs of antitumor activity with monoclonal antibodies against programmed death-1 and its ligand PD-L1, according to findings from two clinical studies presented at the 2015 ASCO Annual Meeting.
Study Shows First-Time Survival Benefit for Soft Tissue Sarcoma
June 2nd 2015Marking the first time a phase III study has shown a survival advantage for patients with soft tissue sarcoma, treatment with eribulin (Halaven) demonstrated improved overall survival (OS) by 2 months compared with dacarbazine in patients with advanced leiomyosarcoma (LMS) and adipocytic sarcoma (ADI).
Combining Ofatumumab With Chemotherapy Delays Progression in CLL
April 29th 2015Topline findings from the phase III COMPLEMENT 2 study indicated that treatment with ofatumumab (Arzerra) plus fludarabine and cyclophosphamide significantly improved progression-free survival (PFS) compared with fludarabine and cyclophosphamide alone in patients with relapsed chronic lymphocytic leukemia (CLL).
NDA Submitted for MM-398 With 5-FU and Leucovorin in Advanced Pancreatic Cancer
April 28th 2015Following the FDA fast track designation in November 2014, Merrimack Pharmaceuticals and Baxter International have completed the submission of a new drug application for MM-398 in combination with 5-fluorouracil and leucovorin, according to a statement from the drug's developers.
Ibrutinib Regimen Delays Disease Progression in Phase III CLL Trial
March 17th 2015Combination therapy with ibrutinib plus bendamustine and rituximab significantly extended progression-free survival compared with BR alone in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma enrolled in the phase III HELIOS trial.
Neoadjuvant Endocrine Therapy Could Play Role in Treatment of Some Breast Cancers
March 12th 2015While not appropriate for all patients with ER-positive breast cancer, neoadjuvant endocrine therapy could play an important role in select groups of women with comorbidities or those with ER-rich/luminal A disease.
Dinutuximab Approved for High-Risk Neuroblastoma
March 10th 2015Dinutuximab (Unituxin) has been approved by the FDA in combination with interleukin-2, granulocyte-macrophage colony-stimulating factor (GM-CSF), and isotretinoin as a frontline therapy for pediatric patients with high-risk neuroblastoma.