After granting a priority review to durvalumab (Imfinzi) in October for the treatment of patients with stage III, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation, the FDA is now reviewing results from the phase III PACIFIC trial, which have now been published in the print edition of the New England Journal Medicine.
The FDA has approved the IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling assay, an in vitro diagnostic test that can identify more tumor biomarkers than any test previously reviewed by the agency.
The anti–B-cell maturation antigen chimeric antigen receptor T-cell therapy bb2121 has been granted a breakthrough therapy designation by the FDA for previously treated patients with relapsed/refractory multiple myeloma.
Progression-free survival was extended by 3.6 months with higher-dose, once-weekly carfilzomib (Kyprolis) compared with a lower-dose, twice-weekly regimen in patients with relapsed/refractory multiple myeloma, according to according to phase III results from the ARROW trial.
Fulvestrant (Faslodex) has been approved by the FDA for use in combination with the CDK4/6 inhibitor abemaciclib (Verzenio) as a treatment for patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after endocrine therapy.
According to results from the phase III phase III LyMa trial published in the <em>New England Journal of Medicine, </em>survival was improved for patients with mantle cell lymphoma with maintenance rituximab (Rituxan) following autologous stem-cell transplantation (ASCT).
The use of atezolizumab (Tecentriq) is being recommended by the UK's National Institute for Health and Care Excellence (NICE) for treatment-naïve patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-based therapy.
The B-cell maturation antigen antibody-drug conjugate GSK2857916 has been granted a breakthrough therapy designation by the FDA for the treatment of patients with relapsed/refractory multiple myeloma, GlaxoSmithKline has announced.
According to 10-year results from the TEAM study,
An overall response rate of 16% was demonstrated in patients with FGF 19 immunohistochemistry-positive hepatocellular carcinoma treated with BLU-554, which was higher than the response rates of 10% or less that are seen with the currently approved HCC treatments.
A supplemental biologics application for bevacizumab (Avastin) has been accepted by the FDA for the first-line treatment of advanced ovarian cancer, according to Genentech, the manufacturer of the angiogenesis inhibitor.
According to phase II results from the DSMM XI trial published in the <em>British Journal of Haematology</em>, induction therapy with bortezomib (Velcade), cyclophosphamide, and dexamethasone demonstrated an overall response rate of 85.4% in treatment-naïve patients with multiple myeloma.
In patients with newly diagnosed multiple myeloma, maintenance therapy with lenalidomide (Revlimid) induced a survival benefit following autologous stem-cell transplantation, according to results from a meta-analysis published in the <em>Journal of Clinical Oncology</em>.
According to data from the phase II OMS-I102 trial presented at the 2017 World Congress of Melanoma, the immune stimulator ImmunoPulse IL-12 induced promising activity when added to pembrolizumab (Keytruda) in patients with melanoma who have been identified as unlikely responders to anti–PD-1 therapies.
The combination of dabrafenib and trametinib has been granted a breakthrough therapy designation by the FDA for the adjuvant treatment of patients with stage III melanoma with a <em>BRAF V600</em> mutation following complete resection.
A supplemental New Drug Application for olaparib (Lynparza) has been granted a priority review by the FDA for the treatment of patients with germline <em>BRCA</em>-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic settings, AstraZeneca and Merck, the co-developers of the PARP inhibitor, recently announced.
Based on positive progression-free survival results from the PACIFIC trial, a supplemental biologics license application for durvalumab (Imfinzi) for the treatment of patients with stage III, unresectable non–small cell lung cancer has been granted a priority review by the FDA.
Abemaciclib (Verzenio) failed to meet its primary endpoint of improving overall survival versus erlotinib (Tarceva) in patients with <em>KRAS</em>-mutated, advanced non–small cell lung cancer who progressed after platinum-based chemotherapy, according to topline results from the phase III JUNIPER trial.
Osimertinib (Tagrisso) has been granted Breakthrough Therapy Designation by the FDA for the first-line treatment of patients with metastatic <em>EGFR </em>mutation-positive non-small cell lung cancer (NSCLC).
Janssen Biotech has submitted a new drug application to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer, the manufacturer of the next-generation oral androgen receptor inhibitor announced today.
Gilteritinib has been granted Fast Track designation by the FDA for adult patients with FLT3 mutation-positive relapsed/refractory acute myeloid leukemia, according to Tokyo-based Astellas Pharma.
According to a multivariate analysis of the Nordic MCL2 and MCL3 trials, the presence of <em>TP53</em> mutations predicts overall survival in younger patients with mantle cell lymphoma.
While currently-approved treatments for HCC are typically associated with responses rates of 10% or less, findings presented at the 11th Annual Conference of the ILCA, BLU-554, a potent and highly selective inhibitor of fibroblast growth factor receptor 4 (FGFR4), induced an overall response rate of 16% (95% CI, 6-31) in patients with FGF 19 IHC-positive HCC.
Midostaurin has received approval from the European Commission as a treatment for adults with newly diagnosed <em>FLT3</em>-positive acute myeloid leukemia and advanced systemic mastocytosis, including aggressive systemic mastocytosis, SM with associated hematological neoplasm, and mast cell leukemia.
Based on phase III results from the PROSELICA trial, the FDA has approved the combination of cabazitaxel at a dose of 20 mg/m<sup>2</sup> every 3 weeks and prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who previously received a docetaxel-containing regimen.
According to findings presented at the 11th Annual Conference on the International Liver Cancer Association in Seoul, South Korea, BLU-554 induced an overall response rate of 16% in patients with FGF 19 immunohistochemistry-positive hepatocellular carcinoma. BLU-554 is a potent and highly selective inhibitor of fibroblast growth factor receptor 4.
Today, ABP-215, a biosimilar for bevacizumab developed by Amgen and Allergan, received FDA approval for the treatment of several different cancer types, making it the first biosimilar approved for the treatment of cancer.
A biologics license application for the rituximab biosimilar Rixathon has been accepted by the FDA, according to Sandoz, the company developing the treatment. If it receives approval, rixathon would be indicated for follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia, as well as for rheumatoid arthritis.
Multiple trials in Celgene’s FUSION program, which is exploring regimens combining the PD-L1 inhibitor durvalumab (Imfinzi) with immunomodulatory and chemotherapy agents across several hematologic malignancies, have been placed on clinical holds by the FDA.
Partial clinical holds have been placed on 3 trials by the FDA, which are assessing nivolumab (Opdivo)-based combinations in patients with relapsed/refractory multiple myeloma.