A fourth trastuzumab biosimilar has been granted approval by the FDA. The approval was for PF-05280014 for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
The combination regimen of venetoclax and obinutuzumab is seeking FDA approval; a supplemental new drug application has been submitted to the FDA for the combination as a treatment for patients with previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions, according to an announcement from Genentech (Roche).
The highly selective JAK2 inhibitor fedratinib has received a priority review designation by the FDA as a treatment for patients with myelofibrosis. The designation was granted based on findings from the phase III JAKARTA and phase II JAKARTA-2 trials.
The phase III FORWARD I trial fell short of its primary endpoint, as findings showed the antibody-drug conjugate mirvetuximab soravtansine did not result in a progression-free survival improvement compared with chemotherapy in patients with folate receptor alpha–positive, platinum-resistant ovarian cancer and in an overall patient population.
The indication for aprepitant injectable emulsion has been expanded by the FDA to include a 2-minute intravenous use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.
Subcutaneous use of trastuzumab and hyaluronidase-oysk injection has been approved by the FDA in combination with chemotherapy for the treatment of select patients with HER2-positive early breast cancer, in combination with paclitaxel in patients with metastatic HER2-positive breast cancer as a frontline treatment, and alone for patients with metastatic disease who have received at least 1 prior chemotherapy regimen.
Daneng Li, MD, sheds light on some of the currently available regimens and ongoing research efforts being conducted in HCC and NETs.
Merck, the developer of pembrolizumab, has announced that the coprimary endpoints of the KEYNOTE-240 trial were not met, as adding the agent to best supportive care failed to improve progression-free or overall survival in patients with advanced hepatocellular carcinoma who were previously treated with systemic therapy.
Pembrolizumab has been granted a priority review designation by the FDA for the treatment of patients with advanced small cell lung cancer whose disease has progressed following ≥2 prior lines of therapy.
Entrectinib has been granted a priority review designation by the FDA as a therapy for select adult and pediatric patients with <em>NTRK</em> fusion–positive locally advanced or metastatic solid tumors, as well as patients with metastatic <em>ROS1</em>-positive non–small cell lung cancer, according to Genentech, the developer of the multikinase inhibitor.
The PD-1 inhibitor pembrolizumab has gained FDA approval as an adjuvant therapy for patients with high-risk stage III melanoma with lymph node involvement following complete resection.
A supplemental biologics license application for the combination of pembrolizumab and axitinib has received a priority review designation from the FDA as a frontline treatment for patients with advanced renal cell carcinoma, primarily based on data from the phase III KEYNOTE-426 study.
Based on findings from the phase Ib EQUULEUS (MMY1001) trial, a split-dosing regimen of daratumumab has been approved by the FDA for patients with multiple myeloma, providing physicians the option to split the first infusion of the CD38-directed monoclonal antibody over 2 consecutive days or complete in a single session.
The combination of avelumab and axitinib has been given a priority review designation by the FDA for the treatment of patients with advanced renal cell carcinoma.
Findings from the phase III KEYNOTE-426 study demonstrated a significantly improved progression-free survival and overall survival with the combination pembrolizumab plus axitinib versus sunitinib in previously-untreated patients with clear cell metastatic renal cell carcinoma, according to a prescast ahead of the 2019 Genitourinary Cancers Symposium.
Based on data from the phase III KEYNOTE-048 trial, pembrolizumab has received a priority review designation from the FDA alone or in combination with platinum and 5-fluorouracil chemotherapy as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.
The FDA's Oncologic Drugs Advisory Committee will hold a hearing on February 26, 2019, to discuss a new drug application for selinexor in combination with dexamethasone for the treatment of patients with penta-refractory multiple myeloma.
Patients with heavily pretreated metastatic HER2-positive breast cancer saw an improvement in progression-free survival with margetuximab combined with chemotherapy compared with trastuzumab and chemotherapy, according to findings from the phase III SOPHIA trial.
The first treatment regimen has been approved by the FDA to treat adult patients with acquired thrombocytic thrombocytopenic purpura: the nanobody caplacizumab-yhdp when given in combination with plasma exchange and immunosuppression.
Based on findings from the phase III ENLIVEN study, a new drug application for the investigational, small molecule, CSF1R receptor inhibitor pexidartinib has been granted a priority review by the FDA for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.
Based on a recommendation from the FDA, Aveo Oncology has decided not to submit a new drug application for tivozanib. The FDA has advised it was not satisfied with the preliminary overall survival data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma.
In topline findings from the phase III TITAN trial announced today by Janssen, apalutamide in combination with androgen deprivation therapy significantly improved radiographic progression-free survival and overall survival versus placebo in patients with metastatic castration-sensitive prostate cancer.
Based on data from the phase III KEYNOTE-189 trial, the FDA has expanded the approval for pemetrexed injection in combination with pembrolizumab and platinum-based chemotherapy to include the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer without <em>EGFR</em> or <em>ALK</em> alterations.
The combination of ibrutinib and obinutuzumab has gained FDA approval for the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, based on data from the phase III iLLUMINATE trial.
Bristol-Myers Squibb has announced its decision to withdraw a supplemental biologics license application currently with the FDA seeking frontline approval for the combination of nivolumab and ipilimumab for patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
No new patients with advanced soft tissue sarcoma should be treated with the combination of olaratumab plus doxorubicin, according to a statement from the FDA.
A direct-to-consumer genetic test has been approved by the FDA for providing a risk report on MUTYH-associated polyposis, a hereditary colorectal cancer syndrome, according to 23andMe, the personal genetics company that manufactures the test.<br />
The primary endpoint of overall survival benefit with the combination of olaratumab plus doxorubicin was not met for patients with advanced or metastatic soft tissue sarcoma in the phase III ANNOUNCE clinical trial.
Frontline treatment with ibrutinib plus nab-paclitaxel/gemcitabine did not have a statistically significant benefit in progression-free survival or overall survival compared to placebo plus nab-paclitaxel/gemcitabine in patients with metastatic pancreatic cancer.
Umbralisib was granted a breakthrough therapy designation by the FDA for the treatment of adult patients with marginal zone lymphoma who have received 1 prior anti-CD20 regimen.