Nivolumab/Ipilimumab Combo More Effective than Monotherapy in mCRC
June 14th 2016Nivolumab (Opdivo) treatment provided antitumor responses in patients with microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC), whether given as a single agent or in combination with ipilimumab (Yervoy). Interim data from the phase II CheckMate-142 trial was presented at the 2016 ASCO Annual Meeting.
Palbociclib Addition to Letrozole Improved PFS in ER+/HER2- Breast Cancer
June 11th 2016Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting.
Nivolumab Monotherapy Achieves Positive Responses in Classical Hodgkin Lymphoma
June 7th 2016A majority of patients (66%) with classical Hodgkin lymphoma (cHL) who had progressed after receiving autologous stem cell transplant (ASCT) and brentuximab vedotin (adcetris) experienced a response to nivolumab (Opdivo) monotherapy, findings from the phase II CheckMate-205 trial showed when presented at the 2016 ASCO Annual Meeting.
Combination Nivolumab/Ipilimumab Shows Increased PFS Compared with Monotherapy
June 7th 2016Combination therapy nivolumab (Opdivo) and ipilimumab (Yervoy) resulted in reduced disease progression risk of 58% when compared with ipilimumab alone in patients with advanced melanoma. Additionally, nivolumab monotherapy showed greater risk reduction (45%) compared with ipilimumab single-agent treatment.
Sustained Survival Shown in Updated Nivolumab Results in NSCLC
June 7th 2016Updated findings from the phase III CheckMate-057 and -017 trials showed sustained improvements in overall survival (OS) data of nivolumab (Opdivo) treatment in pretreated patients with nonsquamous or squamous non-small cell lung cancer (NSCLC).
Study Links Left-Side Tumors with Improved Survival in mCRC
June 2nd 2016Survival outcomes in patients with KRAS wild-type metastatic colorectal cancer (mCRC) were significantly longer among those with tumors originating on the left versus the right side of the colon, according to a retrospective analysis of the phase III 80405 trial.
FDA Grants Olaratumab Priority Review for Soft Tissue Sarcoma
May 5th 2016The FDA has granted an biologics license application for olaratumab a priority review for use in combination with doxorubicin as a treatment of patients with advanced soft tissue sarcoma who are not good candidates for radiotherapy or surgery.
Blinatumomab Granted Priority Review for Pediatric ALL
May 5th 2016The FDA has granted a priority review to a supplemental biologics license application that would extend the indication for blinatumomab to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Nivolumab Granted FDA Priority Review for Hodgkin Lymphoma
April 15th 2016The FDA has granted nivolumab (Opdivo) a priority review for use in previously treated patients with classical Hodgkin lymphoma (cHL), giving the drug the potential to become the first PD-1 inhibitor approved for a hematologic malignancy.
FDA Committee Denies Rociletinib Accelerated Approval in Lung Cancer
April 13th 2016The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 12-1 against the accelerated approval of rociletinib for patients with metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC) who have previously received an EGFR-targeted therapy.
Correlation Drawn Between Homologous Recombination and Longer Survival in Ovarian Cancer
March 23rd 2016Patients with advanced ovarian cancer harboring mutations in homologous recombination (HR) genes, including BRCA1/2, had improved survival versus patients without HR mutations, according to a mutational analysis of the phase III GOG 218 study.
FDA Considering Approval Expansion for Blinatumomab in Pediatric ALL
March 4th 2016The FDA has received a supplemental biologics license application to expand the approval of blinatumomab to include pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Obinutuzumab Approved by the FDA for Follicular Lymphoma
February 27th 2016Obinutuzumab (Gazyva) plus bendamustine, followed by obinutuzumab alone has been approved by the FDA as a treatment of patients with follicular lymphoma who were not responsive to a rituximab regimen, or who relapsed after rituximab-based therapy.
Durvalumab/Tremelimumab Shows Efficacy in NSCLC
February 16th 2016Patients with advanced non-small cell lung cancer receiving the combination checkpoint blockade with the PD-L1 inhibitor durvalumab and the anti-CTLA-4 agent tremelimumab had a response rate of 23%, according to phase Ib data from Study 006.
T-Cell Therapy Granted FDA Breakthrough Designation in Sarcoma
February 11th 2016The FDA has granted an affinity enhanced T-cell therapy breakthrough therapy designation for patients with inoperable or metastatic pretreated synovial sarcoma who harbor HLA-A*201, HLA-A*205, or HLA-A*206 alleles and whose tumors express the NY-ESO-1 tumor antigen
FDA Assigns Sacituzumab Govitecan Breakthrough Designation for TNBC
February 9th 2016The FDA has granted sacituzumab govitecan (IMMU-132) breakthrough therapy designation for the treatment of patients with triple-negative breast cancer (TNBC) following at least 2 treatments for metastatic disease, according to Immunomedics, the manufacturer of the investigational antibody-drug conjugate.