Final 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.
The 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.
Sunitinib extended disease-free survival versus placebo as an adjuvant therapy for patients with renal cell carcinoma at high risk of recurrence in the phase III S-TRAC trial.
A number of small changes that were specific to neoadjuvant and adjuvant therapies were made to the NCCN breast cancer guidelines, additionally, the recommended treatments for patients with ER-positive disease were also modified.
Nivolumab (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 (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.
When tested in heavily pretreated patients with refractory, hormone-receptor (HR)-positive, HER2-negative advanced breast cancer, abemaciclib, a CDK4/6 inhibitor, produced a positive response rate of approximately 20%.
A 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 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.
Combining PD-L1 inhibitor atezolizumab with investigational OX40 agonist MOXR0916 treatment showed early signs of antitumor activity in solid tumor types and was well tolerated by patients.
Updated 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).
Survival 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.
CPX-351 (Vyxeos) has been granted a breakthrough therapy designation by the FDA as a treatment for patients with therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.
Clovis has stopped clinical development of rociletinib, its once promising EGFR inhibitor for the treatment of patients with EGFR T790M-mutated non-small cell lung cancer (NSCLC).
Second-line treatment with regorafenib improved overall survival compared with best supportive care for patients with unresectable hepatocellular carcinoma following progression on sorafenib.
The 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.
The 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.
Given the numerous available treatment options, the most important issue in frontline colorectal cancer (CRC) care is clarifying the goals of therapy, according to Wells Messersmith, MD.
The FDA has approved afatinib for the treatment of patients with advanced squamous cell non-small cell lung cancer following progression on platinum-based chemotherapy.
The 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.
The 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.
The FDA has granted a priority review to atezolizumab for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who express PD-L1 and have progressed after a platinum-containing regimen.
The FDA approved the BCL-2 inhibitor venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion (del[17p]), following at least 1 prior therapy.
Adding plitidepsin (Aplidin) to dexamethasone reduced the risk of disease progression by 35% versus dexamethasone alone in patients with relapsed/refractory multiple myeloma enrolled in the phase III ADMYRE trial.
Patients 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.
Ibrutinib (Imbruvica) has been approved by the FDA as a frontline treatment for patients with chronic lymphocytic leukemia (CLL), based on data from the phase III RESONATE-2 trial.
The 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 (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.
Blinatumomab (Blincyto), an anti-CD19 agent, had a 69% response rate in patients with non-Hodgkin Lymphoma (NHL), according to updated data from a phase I, open-label, multicenter study.
Palbociclib (Ibrance) has been approved by the FDA for use in combination with fulvestrant in pretreated patients with HR-positive, HER2-negative metastatic breast cancer.