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A supplemental biologics license application has been submitted to the FDA for the use of daratumumab (Darzalex) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone as a treatment for patients with multiple myeloma following at least 1 prior therapy.
Adding custirsen to cabazitaxel (Jevtana) and prednisone in the second-line setting failed to improve overall survival in men with metastatic castration-resistant prostate cancer in the phase III AFFINITY trial.
The phase III MONARCH 2 study assessing abemaciclib in HR-positive, HER2-negative advanced breast cancer will continue after the CDK4/6 inhibitor did not meet the efficacy criteria at an interim analysis required to stop the trial early.
The FDA has approved an extended release injection formulation of granisetron (Sustol) for use in combination with other antiemetic therapies for the prevention of chemotherapy-induced nausea and vomiting.
Combination therapy with cobimetinib (Cotellic) and vemurafenib (Zelboraf) reduced the risk of death by 30% compared with vemurafenib alone in patients with BRAF-positive advanced melanoma.
The FDA has placed a partial clinical hold on a planned pivotal trial examining an investigational T-cell therapy in patients with myxoid round cell liposarcoma.
The European Commission has approved pembrolizumab (Keytruda) as a treatment for patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer following at least 1 chemotherapy regimen.
The FDA has granted pracinostat a breakthrough therapy designation for use in combination with azacitidine as a treatment for patients with newly diagnosed acute myeloid leukemia who are aged ≥75 years or ineligible for intensive chemotherapy.
Brentuximab vedotin (Adcetris) significantly improved the rate of responses lasting at least 4 months in patients with CD-30­–positive cutaneous T-cell lymphoma, meeting the primary endpoint of the phase III ALCANZA trial.
Maintenance lenalidomide following frontline treatment with high-dose melphalan and autologous stem cell transplant reduced the risk of death by 26% versus placebo or no maintenance in patients with multiple myeloma.
Two phase III trials examining afatinib (Gilotrif) in head and neck cancer have been stopped after an independent panel determined the pan-HER inhibitor was unlikely to demonstrate an efficacy benefit over placebo.
The FDA granted daratumumab (Darzalex) a breakthrough therapy designation for use in combination with lenalidomide/dexamethasone or bortezomib/dexamethasone as a treatment for patients with multiple myeloma following at least 1 prior therapy.
Cabozantinib (Cabometyx) has received a positive recommendation from the EMA's Committee for Medicinal Products for Human Use for use as treatment for patients with advanced renal cell carcinoma after the failure of VEGF-targeted therapy.
The CD19-targeting CAR T-cell therapy CTL019 induced responses in 53% of patients with relapsed/refractory chronic lymphocytic leukemia, including complete remissions in 35% of patients.
The hedgehog inhibitor sonidegib (Odomzo) showed continued antitumor activity with no new safety concerns in patients with advanced basal cell carcinoma.
The hedgehog inhibitor vismodegib (Erivedge) had an estimated disease control rate of 92.9% in the STEVIE trial, the largest ever study conducted in advanced basal cell carcinoma.
Adding the anti-CD20 agent obinutuzumab (Gazyva) to CHOP chemotherapy in the frontline setting did not improve progression-free survival compared with the standard regimen of rituximab (Rituxan) plus CHOP in patients with diffuse large B-cell lymphoma.
The European Commission has approved lenalidomide for use as a treatment for patients with relapsed or refractory mantle cell lymphoma.
The progression-free survival benefit with lenvatinib over placebo in patients with radioactive iodine–refractory differentiated thyroid cancer was sustained in an updated analysis of the phase III SELECT trial.
The FDA granted the selective tropomyosin receptor kinase inhibitor LOXO-101 a breakthrough therapy designation for the treatment of adult or pediatric patients with unresectable or metastatic solid tumors with NTRK-infusion proteins who progressed on prior therapy or have no other available treatment options.
Pembrolizumab (Keytruda) demonstrated promising antitumor activity with durable responses in patients with advanced thyroid cancer.
Sunitinib (Sutent) extended disease-free survival versus placebo as an adjuvant therapy for patients with renal cell carcinoma at high risk of recurrence in the phase III S-TRAC trial.
PD-L2 and the IFN-γ 6-gene signature may offer options beyond PD-L1 to predict response to pembrolizumab (Keytruda) in patients with recurrent or metastatic head and neck squamous cell carcinoma.
Adding the pan-PI3K inhibitor buparlisib (BKM120) to chemotherapy reduced the risk of disease progression or death by 35% in patients with advanced head and neck squamous cell carcinoma.
The European Commission has approved brentuximab vedotin (Adcetris) for use as a consolidation therapy following autologous stem cell transplantation in patients with CD30-positive Hodgkin lymphoma at risk of relapse or progression.
Members of the Pediatric Subcommittee of the FDA's Oncologic Drugs Advisory Committee voiced their support for new clinical trials examining promising cancer agents in pediatric patients.
The EMA's Committee for Medicinal Products for Human Use has granted a positive opinion for use of pembrolizumab (Keytruda) as a treatment for patients with locally advanced or metastatic PD-L1-positive non–small cell lung cancer.
The FDA has granted nivolumab (Opdivo) a breakthrough therapy designation for the treatment of patients with unresectable locally advanced or metastatic urothelial carcinoma after the failure of a platinum-containing regimen.
The FDA has granted a breakthrough therapy designation to ruxolitinib for the treatment of patients with acute graft-versus-host disease.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion to ofatumumab regarding its potential use in the maintenance setting for patients with relapsed chronic lymphocytic leukemia.
