The 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.
AstraZeneca 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.
Findings 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.
Based 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.
According 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.
An 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.
Lenalidomide 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.
Pembrolizumab 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.
According 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.
Progression-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.
The 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.
A 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 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%.
Using 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 (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.
A 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.
Based 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.
Pembrolizumab (Keytruda) has received an accelerated approval from the FDA for the treatment of patients with hepatocellular carcinoma who have previously received sorafenib (Nexavar).
According 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.
Novel agents and treatment strategies continue to expand the armamentarium in follicular lymphoma, explained John P. Leonard, MD, in a session at the <em>36th Annual </em>CFS<span style="font-size:10.8333px">.</span>
Based 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.
Based 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 (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.
Newly 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.
Based 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.
Three 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.
A 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.
Patients 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.
A 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 />
Cemiplimab (Libtayo) has been approved by the FDA for the treatment of patients with metastatic cutaneous squamous cell carcinoma or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.