Jason M. Broderick
Articles
Triplet Regimen Could Replace Standard of Care for Transplant-Ineligible Myeloma
December 5th 2018According to the phase III MAIA trial, triplet regimen daratumumab, lenalidomide, plus dexamethasone reduced risk of disease progression or death by 44% in newly diagnosed patients with multiple myeloma who were not candidates for high-dose chemotherapy and autologous stem-cell transplant, compared to patients who received lenalidomide plus dexamethasone.
Consistent OS Benefit Seen Across Patient Subgroups With Quizartinib in AML
December 5th 2018An update on the pivotal phase III QuANTUM-R study presented at the 2018 ASH Annual Meeting demonstrated overall survival benefit across patient subgroups with quizartinib in patients with relapsed/refractory <em>FLT3</em>-ITD–mutated acute myeloid leukemia.
Significant PFS Benefit Seen With R2 Regimen in Indolent NHL
December 4th 2018Lenalidomide in addition to rituximab, called the R<sup>2</sup> regimen, led to a significant increase in progression-free survival compared with rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma in results from the phase III AUGMENT trial.
Triplet Regimen Induced 90% Response Rate in Patients With CLL
December 3rd 2018Pembrolizumab in combination with umbralisib and ublituximab induced responses in 90% of patients with relapsed/refractory chronic lymphocytic leukemia, according to data from a phase I/II study presented at the 2018 ASH Annual Meeting. Additionally, a 50% response rate was also demonstrated in patients with Richter’s transformation.
Toxicity Reduced With Fewer Lines of CHOP Plus Rituximab in DLBCL
December 2nd 2018According to findings from the FLYER trial presented at the 2018 ASH Annual Meeting, treatment with 2 fewer frontline cycles of R-CHOP greatly reduced toxicity in younger patients with low-risk diffuse large B-cell lymphoma. The progression-free survival rates were also similar between the 2 arms.
Ibrutinib Significantly Improves PFS in Older Untreated Patients With CLL
December 2nd 2018Progression-free survival was significantly improved with both ibrutinib as monotherapy and in combination with rituximab when compared to bendamustine plus rituximab as a treatment for older patients with newly diagnosed chronic lymphocytic leukemia. These data were presented at the 2018 ASH Annual Meeting.
Larotrectinib Granted FDA Approval for NTRK+ Cancers
November 27th 2018The FDA has granted an accelerated approval to larotrectinib (Vitrakvi) for use in adult and pediatric patients with solid tumors that have an <em>NTRK</em> gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
FDA Grants Priority Review Designation to Quizartinib for FLT3-ITD+ AML
November 26th 2018A new drug application for quizartinib has been granted a priority review by the FDA for the treatment of adult patients with relapsed/refractory <em>FLT3</em>-ITD–positive acute myeloid leukemia. The designation is based on findings from the phase III QuANTUM-R study.
Blinatumomab Receives Recommendation for European Approval in MRD+ ALL
November 20th 2018Blinatumomab has received support from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The agent has been recommended for approval as a treatment of adult patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.
Durvalumab Combo Falls Short in Frontline Metastatic NSCLC
November 17th 2018Using durvalumab (Imfinzi) combined with tremelimumab for the frontline treatment of patients with metastatic non–small cell lung cancer did not result in a statistically significant improvement in overall survival compared to standard chemotherapy, according to a press release from AstraZeneca.
Brentuximab Vedotin Granted FDA Approval for Frontline CD30+ PTCL
November 16th 2018Brentuximab vedotin (Adcetris) has been granted FDA approval for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma, based on findings from the phase III ECHELON-2 trial.
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.
