Pomalidomide in combination with bortezomib and low-dose dexamethasone demonstrated an improved median progression-free survival compared with bortezomib and low-dose dexamethasone alone in patients with relapsed/refractory multiple myeloma who have previously received lenalidomide, according to results from the OPTIMISMM trial.
A supplemental new drug application for eltrombopag has been granted a priority review by the FDA for use in combination with standard immunosuppressive therapy as a frontline treatment for patients with severe aplastic anemia, according to Novartis, the manufacturer of the oral thrombopoietin-receptor agonist.
Cabozantinib has been approved by the European Commission for previously untreated patients with intermediate- or poor-risk advanced renal cell carcinoma, based on a meaningful progression-free survival improvement versus sunitinib in the CABOSUN trial, according to Ipsen, which codevelops the treatment with Exelixis.
Crizotinib has been granted a breakthrough therapy designation by the FDA for the treatment of patients with metastatic non–small cell lung cancer with MET exon 14 alterations who progress after receiving platinum-based chemotherapy. Additionally, the kinase inhibitor was granted a designation for use patients with relapsed/refractory ALK+ anaplastic large cell lymphoma.
Based on data from the ongoing phase III ADMIRAL study, a new drug application for gilteritinib has been granted a priority review by the FDA for the treatment of adult patients with <em>FLT3</em> mutation–positive relapsed or refractory acute myeloid leukemia, according to Astellas Pharma, the manufacturer of the FLT3 inhibitor.
A new drug application for larotrectinib has been granted a priority review by the FDA for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an <em>NTRK</em> gene fusion, according to Bayer and Loxo Oncology, the codevelopers of the pan-TRK inhibitor.
According to topline results from the phase III ILLUMINATE trial, the combination of ibrutinib and obinutuzumab improved progression-free survival compared with chlorambucil plus obinutuzumab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
According to results from a posthoc analysis of the phase III SPARTAN trial, apalutamide (Erleada) lowered the risk of PSA progression by 94% in patients with nonmetastatic castration-resistant prostate cancer.
In a cohort of pediatric and young adult patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma, adding nelarabine to escalating-dose methotrexate (C-MTX) induced a 4-year disease-free survival rate of 91%, according to findings released ahead of the 2018 ASCO Annual Meeting.
According to top-line results from the QUADRA study, niraparib met the primary endpoint of overall response as a fourth-line or later treatment in patients with ovarian cancer, regardless of <em>BRCA</em> status.
Olaparib tablets have been approved been the European Commission as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy, regardless of <em>BRCA</em> status.
According to topline findings from the phase III IMblaze370 study, treatment with the combination of the PD-L1 inhibitor atezolizumab and the MEK inhibitor cobimetinib failed to improve overall survival versus regorafenib in patients with locally advanced or metastatic colorectal cancer who were previously treated.
According to findings from the phase III QuANTUM-R study, overall survival was improved with quizartinib compared with chemotherapy in patients with <em>FLT3</em>-ITD–positive relapsed/refractory acute myeloid leukemia after first-line treatment with or without hematopoietic stem cell transplantation.<br />
Based on findings from the phase III IMpower150 trial, a supplemental biologics license application for atezolizumab has been granted a priority review by the FDA for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer.
The FDA has received a supplemental biologics license application seeking approval for pembrolizumab in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer.
In top-line results from part 2 of the phase IIb STORM trial, selinexor induced an overall response rate of 25.4% in patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics, the manufacturer of the oral SINE compound.
Based on data from the phase II JULIET study, tisagenlecleucel has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
A priority review has been granted by the FDA to a biologics license application (BLA) for the PD-1 inhibitor cemiplimab as a treatment for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or those with locally advanced CSCC not eligible for surgery.
Based on data from the phase III COMBI-AD study, the combination of dabrafenib and trametinib has been granted FDA approval for the adjuvant treatment of patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.
Based on data from the phase III KEYNOTE-189 trial, frontline pembrolizumab has been granted a priority review by the FDA for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer, according to Merck, the manufacturer of the PD-1 inhibitor.
A recommendation has been made by the European Medicines Agency’s Committee for Medicinal Products for Human Use to add final overall survival data from the open-label phase III ASPIRE trial to the label for carfilzomib for the treatment of patients with relapsed/refractory multiple myeloma.
Enrollment has been halted by the FDA on clinical trials of tazemetostat in patients with various solid tumors and hematologic malignancies, according to Epizyme, the manufacturer of the EZH2 inhibitor.
The combination of ramucirumab (Cyramza) plus docetaxel led to a positive trend for patients with locally advanced or unresectable metastatic urothelial carcinoma who progressed on platinum-based chemotherapy, however, a statistically significant improvement was not found in overall survival (OS), according to Eli Lilly and Company, the manufacturer of the VEGFR2 inhibitor.
The phase III ADAPT trial investigating rocapuldencel-T in patients with metastatic renal cell carcinoma has been stopped by Argos Therapeutics after findings of an interim analysis revealed the immunotherapy was unlikely to meet any of the primary endpoints.
Based on data from the phase I/II CheckMate-032 trial, nivolumab has been granted a priority review by the FDA for the treatment of patients with small cell lung cancer with disease progression following 2 or more lines of therapy, according to Bristol-Myers Squibb, the manufacturer of the PD-1 inhibitor.
Osimertinib (Tagrisso) has been approved by the FDA as a frontline treatment for patients with non-small cell lung cancer who have tumors harboring EGFR mutations (either exon 19 deletions or exon 21 L858R substitution mutations). This approval is based off results from a recent phase III study.
In findings from the phase I/II ECHO-203 study presented at the 2018 AACR Annual Meeting, there were no clinical responses demonstrated by adding the IDO1 inhibitor epacadostat to the PD-L1 inhibitor durvalumab in patients with pancreatic cancer.
Results from the phase III KEYNOTE-189 trial were presented at the 2018 AACR Annual Meeting, indicating that the combination of pembrolizumab with standard chemotherapy in the frontline setting reduced the risk of death by more than 50% in patients with nonsquamous non-small cell lung cancer without <em>EGFR </em>or <em>ALK</em> mutations.
According to phase III results from the EORTC 1325-MG/KEYNOTE-054 trial presented at the 2018 AACR Annual Meeting and published in the <em>New England Journal of Medicine, </em>adjuvant pembrolizumab (Keytruda) reduced the risk of recurrence or death by 43% in patients with resected, high-risk stage III melanoma.
Overall survival was improved with the PD-1 inhibitor pembrolizumab versus chemotherapy as a frontline treatment for patients with locally advanced or metastatic non–small cell lung cancer and a PD-L1 expression level ≥1%, according to findings from the phase III KEYNOTE-042 trial.<br />