Based on findings from the phase III ARAMIS trial, a new drug application for darolutamide has been submitted to the FDA seeking the investigational agent's approval as a treatment for patients with nonmetastatic castration-resistant prostate cancer, according to the codevelopers of the investigational agent, Bayer and Orion Corporation.<br />
AstraZeneca and Merck, the codevelopers of olaparib, have announced that findings from the phase III POLO trial showed use of the PARP inhibitor as a frontline maintenance for patients with germline <em>BRCA</em>-mutated metastatic adenocarcinoma of the pancreas significantly reduced the risk of disease progression or death versus placebo.
According to findings from the phase III COLUMBA trial in patients with relapsed/refractory multiple myeloma, a subcutaneous formulation of daratumumab is noninferior in terms of inefficacy and pharmacokinetics to the standard intravenous daratumumab.
At a planned interim analysis of the phase III JAVELIN Ovarian 100 study evaluating frontline avelumab in ovarian cancer, an independent panel determined the study would not meet its primary endpoint of progression-free survival. The co-developers of the PD-L1 inhibitor have announced they will terminate the trial on this basis.
Romiplostim has been granted FDA approval for the treatment of pediatric patients aged ≥1 year with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Venetoclax (Venclexta) has been granted an accelerated approval by the FDA for combined use with azacitidine or decitabine or low-dose cytarabine as a treatment for adult patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
According to topline findings from the phase III TIVO-3 trial, tivozanib (Fotivda) reduced the risk of disease progression or death by 26% compared with sorafenib (Nexavar) in patients with highly refractory advanced or metastatic renal cell carcinoma.
Treatment-naïve patients with chronic lymphocytic leukemia who had comorbidities saw a reduction in the risk of disease progression or death after treatment with venetoclax combined with obinutuzumab versus obinutuzumab plus chlorambucil.
Based on data from the phase III TAGS trial, a supplemental new drug application seeking approval for TAS-102 (trifluridine/tipiracil; Lonsurf) for use in previously treated patients with advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction, has been granted a priority review by the FDA.
Patients with advanced or metastatic renal cell carcinoma who were treated with the combination of pembrolizumab (Keytruda) and axitinib (Inlyta) demonstrated a significantly improved survival benefit compared with sunitinib (Sutent) in the first-line setting, meeting the endpoints of the pivotal phase III KEYNOTE-426 trial.
Gardasil 9 (HPV 9-valent Vaccine, Recombinant), a vaccine for the prevention of HPV, has been approved by the FDA for use in males and females aged 9 through 45 years.
A new drug application for selinexor has been granted a priority review by the FDA as a treatment for patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics, the manufacturer of the agent.
ASCO has revealed its first clinical trial, which will provide patients with limited options an opportunity to receive a potentially beneficial targeted therapy that matches their distinct genetic make-up and is FDA-approved for another type of cancer.