Jason M. Broderick
Articles
Atezolizumab Receives Priority Review Designation From FDA for Frontline Treatment of TNBC
November 13th 2018A supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel has been granted a priority review by the FDA for the treatment of patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer, based on data from the phase III IMpassion130 trial.
Olaparib Granted Priority Review by FDA for Frontline Maintenance in Ovarian Cancer
November 12th 2018Based on data from the phase III SOLO-1 trial, a supplemental new drug application for olaparib tablets has been granted a priority review by the FDA for use as a maintenance therapy in patients with newly-diagnosed,<em> BRCA</em>-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.
Advanced CSCC Landscape Appears Promising After PD-1 Inhibitor Approval
November 9th 2018According to Anna C. Pavlick, BSM, MS, DO, MBA, the treatment landscape for cutaneous squamous cell carcinoma has changed dramatically in September 2018. During her session at the <em>36th Annual</em> CFS<sup>®</sup>, she said this is due to PD-1 inhibitor cemiplimab, the first agent approved specifically for advanced CSCC.
Elotuzumab Triplet Approved by FDA for Treatment of Myeloma
November 7th 2018Based on data from the phase II ELOQUENT-3 trial, elotuzumab (Empliciti) has received approval from the FDA in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.
Brentuximab Vedotin Submitted for FDA Approval in Frontline CD30+ PTCL
November 6th 2018Based on findings from the phase III ECHELON-2 trial, brentuximab vedotin (Adcetris) has been submitted to the FDA for approval in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
Lorlatinib Granted Approval by FDA for ALK+ NSCLC
November 3rd 2018Lorlatinib (Lorbrena) has been granted an accelerated approval by the FDA for use in patients with <em>ALK</em>-positive metastatic non–small cell lung cancer who have progressed on 1 or more ALK tyrosine kinases inhibitors.
Daratumumab Added to Lenalidomide and Dexamethasone Improves Survival in Frontline Myeloma
October 31st 2018Newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplant saw a 45% reduction in the risk of disease progression or death with the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone compared with lenalidomide/dexamethasone alone.
Ruxolitinib Granted Priority Review by FDA for GVHD
October 27th 2018Based on data from the phase II REACH1 trial, a supplemental new drug application for ruxolitinib has been granted a priority review designation by the FDA for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids. The designation was announced by Incyte, the manufacturer of the JAK1/JAK2 inhibitor.
FDA Adds 3 Months to Review Period for Nivolumab Plus Ipilimumab for TMB-High NSCLC
October 23rd 2018Three months have been added on by the FDA to the review period for the supplemental biologics license application for the frontline treatment combination of nivolumab plus low-dose ipilimumab for patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
Ibrutinib and Obinutuzumab Combo Granted Priority Review by FDA For Frontline CLL
October 17th 2018A supplemental new drug application for ibrutinib (Imbruvica) has been granted a priority review by the FDA for use in combination with obinutuzumab (Gazyva) as a frontline treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Survival Improvement Seen With Frontline Brentuximab Vedotin in CD30+ PTCL
October 2nd 2018Patients with CD30-expressing peripheral T-cell lymphoma who were treated with the combination of brentuximab vedotin and frontline chemotherapy experienced a statistically significant improvement in progression-free and overall survival, according to topline results from the phase III ECHELON-2 trial.
Once-Weekly Carfilzomib Regimen Approved by the FDA for Myeloma
October 1st 2018A once-weekly dosing option of carfilzomib (Kyprolis) has been approved by the FDA for use in combination with dexamethasone for patients with relapsed/refractory multiple myeloma, Amgen, the manufacturer of the agent, has announced.<br />
European Commission Approves BRAF/MEK Combination for BRAF+ Melanoma
September 21st 2018According to an announcement from Array BioPharma, the company developing the regimen, the European Commission approved the combination of encorafenib, a BRAF inhibitor, and binimetinib, a MEK inhibitor, for treatment of adult patients with <em>BRAF</em> V600–mutant unresectable or metastatic melanoma.
Venetoclax CLL Label Updated by FDA to Include MRD Data
September 13th 2018Minimal residual disease data from the phase III MURANO trial has been added to the label for venetoclax (Venclexta) by the FDA for its approved use in combination with rituximab (Rituxan) for previously-treated patients with chronic lymphocytic leukemia.
PFS Improvement Seen With Avelumab/Axitinib Combo in Frontline RCC
September 12th 2018Progression-free survival was significantly improved in treatment-naïve patients with advanced renal cell carcinoma by combining the PD-L1 inhibitor avelumab (Bavencio) with the VEGF inhibitor axitinib (Inlyta) compared with sunitinib, according to findings from the phase III JAVELIN Renal 101 study.
Pembrolizumab Combo Receives Approval in Europe for Nonsquamous NSCLC
September 10th 2018Frontline pembrolizumab (Keytruda) has been approved by the European Commission for use in combination with standard chemotherapy as a treatment for patients with metastatic nonsquamous non–small cell lung cancer without <em>EGFR</em> or <em>ALK</em> mutations. The approval is based on results from the phase III KEYNOTE-189 trial.
Pembrolizumab Granted Priority Review by FDA for Merkel Cell Carcinoma
September 4th 2018A supplemental biologics license application for pembrolizumab (Keytruda) has been granted a priority review by the FDA for the treatment of pediatric and adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The application is seeking accelerated approval for the PD-1 inhibitor, manufactured by Merck.
Dasatinib Application for Pediatric Ph+ ALL Accepted by FDA
August 31st 2018A supplemental biologics license application for dasatinib (Sprycel) for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia has been accepted by the FDA.
Europe Approves Adjuvant Dabrafenib/Trametinib for BRAF+ Melanoma
August 30th 2018The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) has gained approval from the European Commission for the adjuvant treatment of patients with <em>BRAF </em>V600–positive stage III melanoma following complete resection.
Blinatumomab Granted European Approval for Treatment of Pediatric ALL
August 29th 2018Blinatumomab (Blincyto) has been approved by the European Commission for the treatment of pediatric patients with Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia that is refractory or in relapse after receiving at least 2 prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
Axicabtagene Ciloleucel Gains Approval in Europe for DLBCL, PMBCL
August 28th 2018Axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the European Commission as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma, following at least 2 lines of systemic therapy.
Tisagenlecleucel Granted Approval in Europe for DLBCL, ALL
August 27th 2018Tisagenlecleucel has gained approval from the European Commission as a treatment for adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.
Ibrutinib Plus Rituximab Approved by FDA for Waldenstrom Macroglobulinemia
August 27th 2018Based on findings from the phase III iNNOVATE trial, ibrutinib has been approved by the FDA in combination with rituximab for patients with Waldenström macroglobulinemia across all lines of therapy.<br />
Elotuzumab Triplet Granted Priority Review by FDA for Myeloma
August 23rd 2018A supplemental biologics license application for elotuzumab<em> </em>has been granted a priority review by the FDA for use in combination with pomalidomide and low-dose dexamethasone as a treatment for patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.<br />
Pembrolizumab Plus Chemotherapy Received Full FDA Approval for NSCLC
August 20th 2018Pembrolizumab has been granted a full approval by the FDA in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer. The approval is based on results from the phase III KEYNOTE-189 trial.
