Pracinostat Receives Breakthrough Designation from FDA for Treatment of AML
August 2nd 2016Pracinostat has received a breakthrough therapy designation from the FDA, when given in combination with azacitidine, for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) aged 75 years or older, or for those who are ineligible for intensive chemotherapy, according to MEI Pharma, the company developing pracinostat.
Daratumumab Receives Breakthrough Designation for Use in Combo Treatments for Myeloma
July 27th 2016Daratumumab (Darzalex) has been granted a breakthrough therapy designation by the FDA for use in the treatment of patients with multiple myeloma following at least 1 prior therapy. The CD38-targeted antibody is accepted for use in combination with lenalidomide/dexamethasone or bortezomib/dexamethasone, according to Janssen, which is developing daratumumab with Genmab.
Final Results for Phase III Trial of CPX-351 Reveal Reduced Mortality Risk in AML
July 22nd 2016Final data from a phase III trial of CPX-351 (Vyxeos) in older patients with high-risk, secondary acute myeloid leukemia (AML) revealed that CPX-351 reduced the mortality risk by 31% compared with cytarabine and daunorubicin (7+3), according to findings presented at the 2016 ASCO Annual Meeting.
Following Favorable Findings, Nivolumab Receives Breakthrough Therapy Designation for mUC
July 15th 2016The FDA has granted nivolumab a breakthrough therapy designation for the treatment of patients with resectable locally advanced or metastatic urothelial carcinoma after the failure of a platinum-containing regimen.
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).