A biologics license application for sacituzumab govitecan has been granted a priority review by the FDA for the treatment of patients with metastatic triple-negative breast cancer following at least 2 prior therapies for metastatic disease, Immunomedics, the manufacturer of the antibody-drug conjugate, has announced.
The FDA has received a supplemental New Drug Application for venetoclax in combination with a hypomethylating agent or low-dose cytarabine as a frontline treatment for patients with acute myeloid leukemia who are ineligible for intensive chemotherapy, Genentech, the manufacturer of the BCL-2 inhibitor, has announced.
The PD-1 inhibitor pembrolizumab (Keytruda) has been granted a priority review designation by the FDA for use in previously treated patients with advanced hepatocellular carcinoma, according to Merck, the manufacturer of the agent.
In topline findings from the phase III TOURMALINE-MM3 study, maintenance treatment with the proteasome inhibitor ixazomib improved progression-free survival compared with placebo in adult patients with multiple myeloma who responded to high-dose therapy and autologous stem cell transplant.
An accelerated approval has been granted by the FDA for the combination of nivolumab plus ipilimumab for the treatment of both adult and pediatric patients, over the age of 12 years, with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, following progression on treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Progression-free survival was not improved by combining pixantrone with rituximab compared with gemcitabine plus rituximab in patients with aggressive B-cell non-Hodgkin lymphoma enrolled in the phase III PIX306 trial, according to CTI BioPharma, the manufacturer of pixantrone.
Dasatinib has been granted approval by the European Commission as a treatment for children and adolescent patients aged 1 to 18 years with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase, according to Bristol-Myers Squibb, the manufacturer of the tyrosine kinase inhibitor.
CPX-351, a fixed-combination of daunorubicin and cytarabine, has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of adult patients with newly diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.
In patients with metastatic or unresectable locally advanced triple-negative breast cancer, frontline treatment with atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) significantly reduced the risk of disease progression or death compared with nab-paclitaxel, according to topline results from the phase III IMpassion130 study.
A supplemental biologics license application for first-line pembrolizumab (Keytruda) for use in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) has been granted a priority review by the FDA for the treatment of patients with metastatic squamous non–small cell lung cancer, regardless of PD-L1 expression.
Based on findings from the phase III CheckMate-238 trial, nivolumab (Opdivo) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, according to Bristol-Myers Squibb, the developer of the PD-1 inhibitor.
Based on data from the phase II BRIGHT 1003 study, the FDA has granted a priority review to a new drug application for glasdegib for use in combination with chemotherapy for the frontline treatment of patients with acute myeloid leukemia, according to Pfizer, the developer of the investigational oral smoothened inhibitor.
The combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) has been approved by the FDA for the treatment of patients with<em> BRAF</em>-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test. The approval is based data from the phase III COLUMBUS trial.
In findings from the randomized phase III SOLO-1 trial, olaparib (Lynparza) tablets reduced the risk of disease progression or death compared with placebo as frontline maintenance therapy for women with <em>BRCA</em>-positive advanced ovarian cancer.
Overall survival and progression-free survival were improved with the combination of frontline atezolizumab with chemotherapy compared with chemotherapy alone in patients with extensive-stage small cell lung cancer, meeting the coprimary endpoints of the phase III IMpower133 trial.
A supplemental biologics license application for the use of pembrolizumab as an adjuvant treatment for patients with resected, high-risk stage III melanoma has been accepted by the FDA, according to Merck, the manufacturer of the PD-1 inhibitor.
A supplemental new drug application for ibrutinib in combination with rituximab has been granted a priority review by the FDA. According to Pharmacyclics and Janssen Biotech, the codevelopers of ibrutinib, this combination could be a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.
Based on survival data from the phase III TOWER study, blinatumomab has been granted full marketing authorization by the European Commission for the treatment of adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia, according to Amgen, the developer of the anti-CD19 immunotherapy.
Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or those who have relapsed after 2 or more prior lines of therapy. The approval is based on results from 53 patients with relapsed/refractory PMBCL enrolled in the multicenter, open-label, single-arm KEYNOTE‑170 trial.
Based on results from the phase III GOG-0218 trial, bevacizumab (Avastin) has been approved by the FDA for use in combination with carboplatin and paclitaxel, followed by bevacizumab monotherapy, for the treatment of women with advanced ovarian cancer following initial surgical resection.
Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for the treatment of patients with advanced, PD-L1–positive cervical cancer with disease progression on or after chemotherapy.<br />
A supplemental new drug application adding overall survival data from the phase III ASPIRE trial to the label for carfilzomib (Kyprolis) has been approved by the FDA, according to Amgen, the manufacturer of the proteasome inhibitor. Carfilzomib is approved for use in patients with relapsed or refractory multiple myeloma.
Based on data from the phase III MURANO trial, venetoclax has been granted a regular approval by the FDA for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who has received at least 1 prior therapy.
According to Pfizer, the manufacturer of the PARP inhibitor talazoparib, a priority review was granted by the FDA to a new drug application for this PARP inhibitor for treatment of patients with germline <em>BRCA </em>mutation–positive, HER2-negative locally advanced or metastatic breast cancer.
Results from a phase II trial demonstrated that cemiplimab, a PD-1 inhibitor, induced an overall response rate (ORR) of 47.5% in patients with metastatic cutaneous squamous cell carcinoma.
According to updated data from the phase I/II PIVOT-02 trial presented at the 2018 ASCO Annual Meeting, the combination of NKTR-214 plus the PD-1 inhibitor nivolumab demonstrated promising antitumor activity in patients with advanced solid tumors, particularly in PD-L1–negative patients.
According to findings of an early study presented at the 2018 ASCO Annual Meeting, the combination of pegilodecakin and a PD-1 inhibitor demonstrated an overall response rate of 41% in patients with advanced non–small cell lung cancer.
According to the phase III KEYNOTE-407 trial, when pembrolizumab was added to frontline carboplatin/paclitaxel or nab-paclitaxel, the combination reduced the risk of death by 36% compared with chemotherapy alone for patients with metastatic squamous non–small cell lung cancer. These results were presented at the 2018 ASCO Annual Meeting.
According to the phase III IMpower131 trial findings presented at the 2018 ASCO Annual Meeting, the risk of progression or death was reduced by 29% with the addition of atezolizumab to the first-line treatment regimen of carboplatin and nab-paclitaxel versus chemotherapy alone for patients with advanced squamous non–small cell lung cancer.
Risk of disease progression or death decreased by 80% with the addition of ibrutinib to rituximab compared with rituximab alone for patients with Waldenström macroglobulinemia.