Jason M. Broderick
Articles
Phase III NALA Trial Results in Higher PFS With Neratinib Combo for HER2+ Breast Cancer
June 6th 2019Combining 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.
PFS Prolonged With Olaparib in Patients With BRCA+ Ovarian Cancer
June 5th 2019Compared 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.
First-in-Class Inhibitor Induces Responses in KRAS G12C+ NSCLC
June 4th 2019Half 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.
Frontline Ramucirumab Combo Delays Progression in EGFR+ NSCLC
June 4th 2019When 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.
Risk of Progression Reduced With Isatuximab Triplet in Phase III Multiple Myeloma Trial
June 3rd 2019Progression-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 />
Lurbinectedin Monotherapy Demonstrates Promising Responses in Second-Line SCLC
June 2nd 2019Single-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.
Survival Is Improved in Metastatic Castration-Sensitive Prostate Cancer With Apalutamide
June 1st 2019Patients 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>
Tazemetostat Submitted for FDA Approval in Epithelioid Sarcoma
May 31st 2019A 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.
Lenalidomide/Rituximab Receives FDA Approval for Indolent Non-Hodgkin Lymphoma
May 28th 2019The 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.
Promising Responses Seen With Entrectinib in Pediatric Cancers, Including CNS Tumors
May 16th 2019One-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.
FDA Panel Votes Not to Back Quizartinib Approval in AML
May 15th 2019In 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.
Bevacizumab/Erlotinib Combination Provides Another Frontline Option in EGFR+ NSCLC
April 17th 2019Adding 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.
FDA Puts Enrollment Hold on Venetoclax Myeloma Trials
March 19th 2019A 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.
FDA Extends Review of Selinexor Application for Myeloma
March 15th 2019Following 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.
FDA Panel Not in Support of Accelerated Approval of Selinexor in Myeloma
February 27th 2019In 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.
TAS-102 Receives FDA Approval for Gastric/GEJ Cancer
February 25th 2019Based 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.
Ivosidenib Receives Priority Review From FDA for Frontline IDH1+ AML
February 21st 2019A 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 Granted Priority Review Designation by FDA for DLBCL
February 19th 2019Polatuzumab 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.
Updated Findings Show Sustained OS Benefit With Nivolumab/Ipilimumab Combo in Frontline RCC
February 14th 2019In 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.
Promising Findings Seen With LuPSMA in Heavily Pretreated mCRPC
February 12th 2019Treatment 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.
Review Period for Ruxolitinib in GVHD Extended by FDA
February 8th 2019The 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 />
Adjuvant T-DM1 Submitted for FDA Approval in High-Risk HER2+ Breast Cancer
February 5th 2019A 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.
Frontline Daratumumab Triplet Seeking FDA Approval in Multiple Myeloma
January 23rd 2019FDA 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.
Decision Deadline for First-Line Pembrolizumab in NSCLC Extended by FDA
December 27th 2018The 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.
EU Panel Recommends Approval of Frontline Brentuximab Vedotin Regimen in CD30+ Hodgkin Lymphoma
December 17th 2018The use of brentuximab vedotin in combination with chemotherapy has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use as a frontline treatment for adult patients with CD30+ stage IV Hodgkin lymphoma.
No Survival Benefit Found With Durvalumab in Head and Neck Cancer
December 10th 2018AstraZeneca has reported that the phase III EAGLE trial has missed its primary endpoint, as patients with recurrent or metastatic head and neck squamous cell carcinoma who progressed after platinum-based chemotherapy did not see a survival benefit with durvalumab alone or combined with tremelimumab.
KATHERINE Findings Support T-DM1 as New Adjuvant Standard in High-Risk HER2+ Breast Cancer
December 6th 2018Findings from the phase III KATHERINE study showed adjuvant treatment with ado-trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease recurrence or death by 50% compared with trastuzumab (Herceptin) in patients with HER2-positive early breast cancer who had residual invasive disease following neoadjuvant therapy.
FDA Grants Atezolizumab Plus Chemotherapy Regimen Priority Review for Frontline SCLC
December 5th 2018Based on findings from the phase III IMpower133 study, a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) has been granted a priority review by the FDA for use in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.
