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.
Dacomitinib has been approved by the FDA for the treatment of previously untreated patients with metastatic non–small cell lung cancer with <em>EGFR </em>exon 19 deletion or exon 21 L858R substitution mutations.
According 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.
Minimal 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.
Progression-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.
Frontline 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.
A 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.
A 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.
The 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 (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 (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 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.
Based 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 />