SB3, a trastuzumab biosimilar, has been granted FDA approval for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.
Gina Columbus
Articles by Gina Columbus
In response to a biologics license application submitted for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer who have received at least 2 prior therapies, the FDA has issued a complete response letter to Immunomedics, citing chemistry, manufacturing, and control matters.
According to findings from the KEYNOTE-181 trial, pembrolizumab demonstrated a significant improvement in overall survival in patients with PD-L1–positive advanced or metastatic esophageal or esophageal junction carcinoma who progressed on standard therapy, marking the first time a PD-1 inhibitor has demonstrated a survival improvement in this patient population.
A supplemental biologics license application submitted to the FDA for atezolizumab, carboplatin, and nab-paclitaxel has been accepted. The application, based on findings from the phase III IMpower130 trial, is seeking the agent's approval for patients with metastatic nonsquamous non–small cell lung cancer.
The investigational BTK inhibitor zanubrutinib (BGB-3111) has received a breakthrough therapy designation from the FDA for the treatment of adult patients with mantle cell lymphoma who have previously received at least 1 prior therapy, BeiGene, the company manufacturing the agent, has announced.
ASLAN Pharmaceuticals, the company developing varlitinib (ASLAN001), has announced that a phase II frontline trial investigating the pan-HER inhibitor added to mFOLFOX6 in patients with HER1/HER2 co-expressing advanced or metastatic gastric cancer has missed its primary endpoint.
UroGen has announced topline findings from the ongoing phase III OLYMPUS trial, in which the investigational mitomycin formulation UGN-101 (mitomycin gel) demonstrated a 57% complete response rate in patients with low-grade upper-tract urothelial cancer.
Eli Lilly and Company will acquire Loxo Oncology for an estimated $8 billion in cash, the company has announced.
According to recently announced topline findings, the confirmatory phase III SOLO-3 trial of olaparib has met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in objective response rate in patients with <em>BRCA</em>-mutant ovarian cancer who have relapsed on at least 2 prior lines of therapy
Dasatinib (Sprycel) tablets has been approved by the FDA to be used in combination with chemotherapy for the treatment of pediatric patients ≥1 year of age with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.<br />
Ravulizumab-cwvz has been approved by the FDA as an injection treatment for adults with paroxysmal nocturnal hemoglobinuria, a rare blood disorder that leads to hemolysis.
A longer-acting version of calaspargase pegol-mknl has been approved by the FDA as a component of a multiagent chemotherapy regimen for pediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukemia.
Tagraxofusp-erzs infusion has been approved by the FDA for the treatment of adult and pediatric patients, aged ≥2 years, with blastic plasmacytoid dendritic cell neoplasm.
Pembrolizumab has been granted an accelerated approval by the FDA as a treatment for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
Olaparib has been approved by the FDA as a maintenance therapy for patients with deleterious or suspected deleterious germline or somatic <em>BRCA</em>-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy, as approved by an FDA-approved companion diagnostic assay.
Based on findings from the phase III ARIEL3 trial, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending an expanded approval for single-agent rucaparib as a maintenance treatment for adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
The phase III TAHOE trial evaluating rovalpituzumab tesirine as a second-line treatment for patients with advanced small cell lung cancer has been put on hold, based on a recommendation from an Independent Data Monitoring Committee, according to AbbVie, the developer of the investigational antibody-drug conjugate.<br />
Atezolizumab (Tecentriq) has been approved by the FDA for use in combination with bevacizumab, carboplatin, and paclitaxel as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer. This indication excludes patients with <em>EGFR</em>/<em>ALK</em> aberrations.
According to findings from the phase III ECHELON-2 trial presented at the 2018 ASH Annual Meeting, the use of brentuximab vedotin (Adcetris) in combination with chemotherapy demonstrated a clinically meaningful improvement in progression-free survival and overall survival in patients with CD30-expressing peripheral T-cell lymphoma. These data were also published online in <em>Lancet Oncology</em>.
Adding adjuvant capecitabine to the standard treatment for patients with early-stage triple-negative breast cancer did not lead to a significant improvement in disease-free or overall survival compared with observation, according to findings presented during the 2018 San Antonio Breast Cancer Symposium
A significant reduction in the risk of disease progression or death was observed from treatment with the upfront combination of ibrutinib plus obinutuzumab in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma compared with chlorambucil and obinutuzumab.
According to findings from the phase III TOURMALINE-MM3, a 39% improvement in progression-free survival was demonstrated with 2-year maintenance therapy with ixazomib compared with placebo for patients with newly diagnosed multiple myeloma who had previously achieved a partial response with an induction therapy of a proteasome inhibitor and/or an immunomodulatory agent following autologous stem cell transplant.
Lisocabtagene maraleucel induced an 81.3% best overall response rate and 43.8% complete response in high-risk patients with chronic lymphocytic leukemia who were heavily pretreated and had previously received ibrutinib, according to dose-finding results presented at the 2018 ASH Annual Meeting.
According to a retrospective phase I/II study, over 80% of patients with relapsed or refractory chronic lymphocytic leukemia responded to concurrent treatment with ibrutinib and the CD19-targeted chimeric antigen receptor CAR T-cell therapy, JCAR014.<sup>1</sup> Findings from this study were presented at the 60th American Society of Hematology Annual Meeting.
The FDA has granted approval to the rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy, making it the first biosimilar approved by the FDA for the treatment of patients with NHL.
The CheckMate-451 trial missed its primary endpoint of overall survival with the combination of nivolumab and ipilimumab as a maintenance therapy for patients with extensive-stage small cell lung cancer without disease progression following frontline platinum-based chemotherapy.
Treatment of patients with advanced or metastatic cancers with the transforming growth factor-β receptor type 1 inhibitor LY3200882 demonstrated a tolerable safety profile and early signs of efficacy, according to the results from a first-in-human, dose-escalation phase I trial presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer.
Mutations in 8 high-risk genes are associated with an acute myeloid leukemia (AML) diagnosis, according to a deep sequencing analysis. Hetty Carraway, MD, said that these findings lay the ground work for upcoming research on early detection and novel treatment strategies.
According to the findings from phase III JAVELIN Ovarian 200 trial, avelumab either alone or in combination with pegylated liposomal doxorubicin did not induce a statistically significant improvement in overall survival or progression-free survival in patients with platinum–resistant/refractory ovarian cancer compared to PLD monotherapy.
Nivolumab in combination with low-dose ipilimumab has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use as treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma in the frontline setting, according to Bristol-Meyers Squibb, the developer of both immunotherapy agents.