FDA Approves Bavencio for Bladder Cancer
The Food and Drug Administration has granted an accelerated approval to the PD-L1 inhibitor Bavencio (avelumab) for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
FDA Approves Imfinzi for Bladder Cancer
The Food and Drug Administration has granted accelerated approval for durvalumab for treatment of patients with bladder cancer.
FDA Approves Alunbrig for ALK+ NSCLC
The Food and Drug Administration has granted accelerated approval to Alunbrig (brigatinib) for metastatic ALK-positive non-small cell lung cancer (NSCLC).
FDA Approves Rydapt for AML
The Food and Drug Administration has approved Rydapt (midostaurin) for acute myeloid leukemia (AML).
Stivarga Gains FDA Approval for Liver Cancer
The Food and Drug Administration (FDA) has approved Stivarga as a second-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who have previously received Nexavar.
Ibrance Gets Full FDA Approval for Breast Cancer
Ibrance gained full FDA approval for the treatment of some patients with breast cancer.
A New Formulation for Rituxan Moves Ahead With FDA Committee Vote
All members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted to approve Rituxan for the treatment of some blood cancers.
Zejula Granted FDA Approval for Ovarian Cancer
The FDA has approved Zejula (niraparib) for treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in the maintence setting.
FDA Approves Bavencio for Merkel Cell Carcinoma
Bavencio (avelumab), a PD-L1-inhibitor, gained approval by the Food and Drug Administration (FDA) for some patients with Merkel cell carcinoma.
FDA Approves Kisqali for Breast Cancer Subset
Kisqali (ribociclib), a CDK 4/6 inhibitor, gained approval from the Food and Drug Administration (FDA) for the frontline treatment of postmenopausal women with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.
Keytruda Still Under Review for MSI-H Cancer
The supplemental biologics license application (sBLA) for Keytruda (pembrolizumab) is still under review by the Food and Drug Administration (FDA) to treat MSI-H cancer.
Blincyto Improves Survival for Ph- Relapsed Acute Lymphoblastic Leukemia
In a recent study, Blincyto (blinatumomab) had longer survival rates than standard chemotherapy for certain patients with ALL.
Kyprolis Duo Improves Survival in Multiple Myeloma
Kyprolis (carfilzomib) plus dexamethasone improved overall survival for patients with relapsed or refractory multiple myeloma.
Xermelo Gains FDA Approval for Carcinoid Syndrome Diarrhea
Xermelo (telotristat ethyl) was approved by the Food and Drug Administration (FDA) to treat diarrhea in patients with carcinoid syndrome.
Avelumab Granted Priority Review by the FDA for Metastatic Urothelial Carcinoma
The FDA granted avelumab a priority review to a biologics license application to treat some patients with metastatic urothelial carcinoma, according to the developers of the drug.
FDA Gives Zykadia a Priority Review for Frontline Lung Cancer Treatment
The FDA granted Zykadia a priority review for the frontline treatment of some patients with lung cancer.
Personalizing Treatment With ctDNA in Prostate Cancer
Since it is found in the majority of patients with mCRPC, circulating tumor DNA may be able to lead the way to more personalized prostate cancer care.
Maintenance Revlimid Gains FDA Approval for Multiple Myeloma
The Food and Drug Administration (FDA) approved Revlimid (lenalidomide) for maintenance therapy for some patients with multiple myeloma.
Lynparza Improves Survival in Breast Cancer, According to Recent Study
In a recent phase 3 trial, Lynparza improved progression-free survival in patients with BRCA-positive, HER2-negative breast cancer.
Blincyto Seeks FDA Approval for Leukemia Treatment
A supplemental biologics license application was filed for Blincyto to be approved for certain patients with ALL.
Frontline Lenvima Is Noninferior to Standard Therapy in Liver Cancer Trial
A recent phase 3 trial showed that treatment with Lenvima is noninferior to standard treatment for patients with unresectable liver cancer.
Opdivo Is Promising for Microsatellite Instability-High mCRC
Opdivo is showing benefit for patients with microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC), according to a recent trial.
Tecentriq Gets FDA Priority Review for New Use In Bladder Cancer
Tecentriq (atezolizumab) is being reviewed for the use in additional settings to treat bladder cancer.
Pacritinib's Clinical Hold for Myelofibrosis Is Lifted
The clinical hold on pacritinib was recently lifted by the US Food and Drug Administration (FDA).
Multikinase Inhibitor Gets Priority Review in Liver Cancer
Stivarga was granted a priority review by the FDA to treat certain patients with liver cancer in the second line setting.
Triplet Does Not Improve Survival in Prostate Cancer
Adding Xtandi to Zytiga and prednisone did not improve progression-free survival for patients with metastatic castration-resistant prostate cancer, according to a recent study.
FDA Grants Durvalumab Priority Review for Bladder Cancer
The PD-L1 inhibitor durvalumab was granted a priority review for the treatment of some patients with urothelial carcinoma.
FDA Stops Multiple Trials for Acute Myeloid Leukemia Drug
Several trials testing vadastuximab talirine for use in patients with AML were recently halted, according to the drug's manufacturer.
Rubraca Approved for Advanced Ovarian Cancer
The FDA approved Rubraca for patients with advanced ovarian cancer who already had two or more lines of therapy.
PARP Inhibitor Boosts Response Rates for BRCA+ Breast Cancer
Adding veliparib to a chemotherapy regimen increased response rates for patients with BRCA-positive breast cancer.