Karyopharm Therapeutics has announced that a rolling submission of an FDA new drug application has been completed for selinexor as a treatment for patients with penta-refractory multiple myeloma, based on results from part 2 of the phase IIb STORM trial.
Mogamulizumab-kpkc (Poteligeo) has been approved by the FDA as a treatment for patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.
The triplet combination of the BRAF inhibitor encorafenib, the MEK inhibitor binimetinib, and the EGFR inhibitor cetuximab has been granted a breakthrough therapy designation by the FDA for the treatment of patients with <em>BRAF</em> V600E–mutant metastatic colorectal cancer following 1 or 2 prior lines of treatment in the metastatic setting. The designation will expedite the development and review of the novel triplet in this setting.
Lurbinectedin (PM1183) has been granted orphan drug designation from the FDA for the treatment of patients with small cell lung cancer, according to PharmaMar, the manufacturer of the marine-derived treatment.
The combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) has been granted a breakthrough therapy designation by the FDA as a treatment for patients with advanced and/or metastatic non–microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy. This designation will allow for the expedited development and review of the combination in this setting.
Quizartinib has been granted a breakthrough therapy designation by the FDA for the treatment of adult patients with relapsed/refractory <em>FLT3</em>-ITD–positive acute myeloid leukemia.
Adjuvant nivolumab has been approved by the European Commission as a treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, regardless of <em>BRAF</em> mutation status, based on findings from the randomized phase III CheckMate-238 trial.
The approval of pembrolizumab has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use as a frontline treatment for patients with metastatic nonsquamous non–small cell lung cancer without <em>EGFR</em> or <em>ALK</em> mutations, regardless of PD-L1 expression. The recommendation is based on data from the phase III KEYNOTE-189 trial.
Iobenguane I-131 has been approved by the FDA for the treatment of adult and pediatric patients aged ≥12 years with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy, based on findings from a phase IIb clinical trial that was conducted under the FDA's special protocol assessment.
The primary endpoint of the phase III ALTA-1L trial has been met, as brigatinib was found to reduce the risk of disease progression or death versus crizotinib in adult patients with locally advanced or metastatic <em>ALK</em>-positive non–small cell lung cancer who had not received a prior ALK inhibitor, Takeda Pharmaceutical Company, the manufacturer of brigatinib, has announced.
The R<sup>2</sup> regimen of lenalidomide (Revlimid) with rituximab (Rituxan) significantly improved progression-free survival compared with rituximab monotherapy in the treatment of patients with relapsed/refractory indolent lymphoma, meeting the primary endpoint of the phase III AUGMENT trial, Celegene, the manufacturer of lenalidomide, has announced.
According to findings from the phase III IMpower132 study, the addition of atezolizumab to pemetrexed and cisplatin or carboplatin reduced the risk of disease progression or death compared with chemotherapy alone in patients with advanced nonsquamous non–small cell lung cancer.
Atezolizumab (Tecentriq) has been granted a breakthrough therapy designation by the FDA for use in combination with bevacizumab (Avastin) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma.
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.