The approval of TAS-102 has been backed by the European Medicines Agency's Committee for Medicinal Products for Human Use for the treatment of adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction, in those previously treated with at least 2 prior systemic therapy regimens for advanced disease.
Cemiplimab has been approved by the European Commission for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
A complete response letter has been issued to Daiichi Sankyo from the FDA, alerting the company to the reasons why the new drug application for quizartinib as a treatment of adult patients with relapsed/refractory <em>FLT3</em>-ITD–positive acute myeloid leukemia would not be approved.
Polatuzumab vedotin in combination with bendamustine and rituximab has been granted an accelerated approval from the FDA for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.<br />
Combining neratinib with capecitabine showed a 24% reduction in the risk of disease progression or death compared with lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer who had previously received 2 lines of HER2-targeted therapy, according to the results of the phase III NALA trial presented at the 2019 ASCO Annual Meeting.
Compared to chemotherapy, treatment with the PARP inhibitor olaparib reduced the risk of disease progression or death by 38% in patients with platinum-sensitive, relapsed, germline <em>BRCA1/2</em>-mutated ovarian cancer who had received at least 2 prior chemotherapy regimens, based on topline findings from the confirmatory phase III SOLO3 trial.
Half of patients with <em>KRAS</em> G12C–positive advanced non–small cell lung cancer achieved a response from treatment with the investigational KRAS G12C inhibitor, AMG 510, in a phase I study presented at the 2019 ASCO Annual Meeting.
When the targeted agents ramucirumab and erlotinib were combined, progression was delayed by 7 months in patients with newly diagnosed <em>EGFR</em>-positive non–small cell lung cancer compared to erlotinib alone, according to findings from the phase III RELAY trial.
Progression-free survival was significantly improved with the triplet combination of isatuximab, pomalidomide, and low-dose dexamethasone compared with pomalidomide and dexamethasone alone in patients with relapsed/refractory multiple myeloma, according to findings from the phase III ICARIA-MM trial presented at the 2019 ASCO Annual Meeting.<br />
Single-agent lurbinectedin induced an overall response rate of 35.2% in the second-line setting for the treatment of patients with small cell lung cancer in a phase II basket trial, presented at the 2019 ASCO Annual Meeting.
Patients with metastatic castration-resistant prostate cancer who received apalutamide plus androgen deprivation therapy had a 33% reduced risk of death compared with patients taking androgen deprivation therapy alone in the phase III TITAN trial. Topline results from the trial were presented at the 2019 ASCO Annual Meeting and simultaneously published in the <em>New England Journal of Medicine.</em>
A new drug application for tazemetostat was submitted to the FDA for the treatment of patients with epithelioid sarcoma who are not eligible for curative surgery, according to Epizyme, the manufacturer of the EZH2 inhibitor.
The R<sup>2</sup> regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) has been approved by the FDA for the treatment of patients with previously treated follicular lymphoma and marginal zone lymphoma, based on findings from the phase III AUGMENT trial.
One-hundred percent of pediatric patients with CNS and solid tumors harboring <em>NTRK1/2/3</em>, <em>ROS1</em>, or <em>ALK</em> gene fusions or mutations achieved objective responses with entrectinib, according to the phase I/Ib STARTRK-NG trial data presented in a press cast ahead of the 2019 ASCO Annual Meeting.
In an 8-3 vote, the FDA’s Oncologic Drugs Advisory Committee has recommended against approving a new drug application for quizartinib for adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia. The FDA is now scheduled to make a final decision on the application by August 25, 2019.
Adding bevacizumab to erlotinib significantly improved progression-free survival compared with erlotinib alone in patients with <em>EGFR</em>-positive, advanced nonsquamous non–small cell lung cancer, suggesting the combination may have the potential to become standard of care for this patient population.
A partial clinical hold has been placed on all clinical trials examining venetoclax in multiple myeloma, according to AbbVie, co-developer of the BCL-2 inhibitor with Genentech. This hold, placed by the FDA, halts enrollment of new patients on the studies.
Following a recommendation from the Oncologic Drugs Advisory Committee against the accelerated approval of selinexor for the treatment of patients with penta-refractory multiple myeloma, the FDA has added 3 months to the review period for the new drug application, making the new action date July 6, 2019.
In an 8 to 5 vote, the FDA's Oncologic Drugs Advisory Committee decided against the accelerated approval of a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma. Instead, the committee recommended delaying a decision on the NDA until results are available from the pivotal phase III BOSTON trial.
Based on data from the phase III AUGMENT trial, a supplemental new drug application for the R<sup>2</sup> regimen of lenalidomide plus rituximab has been granted a priority review designation by the FDA as a therapy for patients with previously treated follicular lymphoma and marginal zone lymphoma.
Based on data from the phase III TAGS trial, TAS-102 has been approved by the FDA as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
A supplemental new drug application for ivosidenib has been granted a priority review designation by the FDA for the frontline treatment of patients <em>IDH1</em>-mutant acute myeloid leukemia who are ineligible for standard chemotherapy, according to Agios, the manufacturer of ivosidenib.
Polatuzumab vedotin, an antibody-drug conjugate that has demonstrated a 40% complete response rate in patients with relapsed/refractory diffuse large B-cell lymphoma, has been granted a priority review designation by the FDA in combination with bendamustine and rituximab for the treatment of these patients, according to Genentech, the manufacturer of the agent.
In updated 30-month follow-up data from the phase III CheckMate-214 trial, nivolumab combined with low-dose ipilimumab sustained strong responses and a survival benefit as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma.
Treatment with the novel targeted radiation therapy lutetium-177 PSMA-617 demonstrated strong clinical activity and the potential to improve survival in heavily pretreated men with PSMA-positive metastatic castration-resistant prostate cancer, according to phase II findings to be presented at the 2019 Genitourinary Cancers Symposium.
The review period for a supplemental new drug application for ruxolitinib has been extended by the FDA by 3 months, making the new action date May 24, 2019. The application is seeking the approval of the JAK1/JAK2 inhibitor as a treatment for patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.<br />
A supplemental Biologics License Application for ado-trastuzumab emtansine (T-DM1; Kadcyla) has been submitted to the FDA seeking approval for the agent as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.
FDA approval is being sought for the combination of daratumumab with lenalidomide and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant. Genmab, which co-develops daratumumab with Janssen Biotech, announced that a supplemental Biologics License Application has been initiated with the FDA.
Cabozantinib has been approved by the FDA for the treatment of patients with hepatocellular carcinoma who previously received sorafenib, Exelixis, the company developing the agent, announced today.
The review period for a supplemental biologics license application for first-line treatment with pembrolizumab monotherapy for the treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer with PD-L1 expression (tumor proportion score) of ≥1% and no <em>EGFR </em>or <em>ALK </em>genomic tumor aberrations has been extended by the FDA, according to a press release by Merck, the manufacturer of pembrolizumab.