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 />
According to findings from the phase III ATLAS trial, disease-free survival was not extended with adjuvant axitinib (Inlyta) versus placebo for patients at high risk of recurrent renal cell carcinoma after nephrectomy.
A new drug application seeking a full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma has been granted a priority review by the FDA.
Based on findings from the phase III ARIEL3 trial, rucaparib (Rubraca) tablets have been approved by the FDA for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, according to Clovis Oncology, the manufacturer of the PARP inhibitor.
According to findings from the phase III ECHO-301/KEYNOTE-252 trial, progression-free survival was not improved with the combination of the PD-1 inhibitor pembrolizumab (Keytruda) and the IDO1 inhibitor epacadostat versus single-agent pembrolizumab in patients with unresectable or metastatic melanoma.
According to Pfizer, manufacturer of a pan-human EGFR tyrosine kinase inhibitor (TKI), a priority review has been granted by the FDA for their TKI inhibitor, dacomitinib, in the frontline setting for patients with <em>EGFR</em>-positive locally advanced or metastatic non–small cell lung cancer.
Based on data from the phase III 482 study, denosumab (Xgeva) has been approved for an expanded indication by the European Commission for the prevention of skeletal-related events in adult patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.
Based on findings from the phase III ECHELON-1 trial, brentuximab vedotin (Adcetris) has been approved by the FDA for use in combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma, according to a statement from Seattle Genetics, the manufacturer of the CD30-targeted antibody-drug conjugate.
According to topline findings from the phase III IMpower131 trial, the addition of atezolizumab (Tecentriq) to frontline carboplatin and nab-paclitaxel delayed progression or death compared with chemotherapy alone for patients with advanced squamous non–small cell lung cancer. These results were released by Genentech, the manufacturer of the anti–PD-L1 agent.
Uttara Nayar, PhD, shares the findings of recent studies in patients with ER+ breast cancer. Findings have shown that acquired HER2 mutations lead to endocrine resistance, the most frequent cause of breast cancer mortality in the country.
External beam radiation therapy can be effective when integrated in a multimodality treatment strategy for patients with relapsed/refractory follicular lymphoma, according to findings from a small, retrospective study.
According to results from the phase III MONALEESA-7 trial presented at the 2018 Miami Breast Cancer Conference, the progression-free survival benefit for ribociclib in pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer had been sustained across patient subgroups.
Based on data from the phase III S-TRAC trial,<span style="font-size:10.8333px"> </span>the European Medicines Agency’s Committee for Medicinal Products for Human Use recently recommended against approving sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.
The FDA has approved a 4-week dosing schedule for the PD-1 inhibitor nivolumab (Opdivo) across several indications.
Based on data from the phase III MONARCH 3 trial, abemaciclib has been granted FDA approval for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.
In findings from the phase III COLUMBUS trial, the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved survival versus single-agent vemurafenib (Zelboraf) in patients with <em>BRAF</em>-mutant advanced, unresectable or metastatic melanoma.
Based on results from the phase III PACIFIC trial, durvalumab has been granted approval by the FDA for the treatment of patients with locally advanced, unresectable stage III non–small cell lung cancer who have not progressed following chemoradiotherapy.