RFS Benefit in Melanoma Sustained at 3 Years With Adjuvant Nivolumab/Ipilimumab
October 24th 2017According to data presented at the 2017 World Congress of Melanoma, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) induced a 3-year relapse-free survival rate of 71% in the adjuvant treatment of patients with high-risk resected stage IIIC/IV melanoma, but it was also associated with significant toxicity.
Frontline Abemaciclib Receives FDA's Priority Review for HR+/HER2- Advanced Breast Cancer
October 12th 2017Based on data from the phase III MONARCH 3 trial, a new drug application for abemaciclib (Verzenio) has been granted a priority review by the FDA for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
sNDA Submitted to FDA for Maintenance Rucaparib Approval in Ovarian Cancer
October 11th 2017Based on findings from the phase III ARIEL3 trial, a supplemental new drug application has been submitted to the FDA for rucaparib as maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Pertuzumab Granted Priority Review by FDA for HER2+ Breast Cancer
September 29th 2017A supplemental biologics license application for pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer has been granted a priority review by the FDA.
Abemaciclib Approved by FDA for Use in HR+/HER2- Breast Cancer
September 28th 2017Abemaciclib (Verzenio) has been approved by the FDA for use as a monotherapy and in a combination regimen for patients with HR-positive/HER2-negative breast cancer. As a monotherapy, the CDK4/6 inhibitor has been approved for patients with metastatic disease who have previously received endocrine therapy and chemotherapy, and as a combination, abemaciclib has been approved for use with fulvestrant for women with advanced breast cancer with disease progression following endocrine therapy.
Pembrolizumab Receives FDA Approval for PD-L1+ Gastric Cancer
September 23rd 2017Based on findings from the phase II KEYNOTE-059 study, pembrolizumab has been granted FDA approval for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.
ODAC Vote Split on Potential Approval of Adjuvant Sunitinib in High-Risk RCC
September 20th 2017The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-6 on the potential approval of sunitinib (Sutent) for use as an adjuvant therapy in patients with renal cell carcinoma (RCC) who have received nephrectomy and are at high risk of recurrence. The FDA will take this vote into consideration when determining its final approval decision, which is scheduled to be made by January 2018.
Copanlisib Receives Accelerated FDA Approval for Follicular Lymphoma
September 14th 2017Based primarily on findings from the phase II CHRONOS-1 trial, copanlisib (Aliqopa) has received an accelerated approval from the FDA as a treatment for patients with relapsed follicular lymphoma who have received at least 2 prior systemic therapies.
Pembrolizumab Receives European Approval for Treatment of Urothelial Carcinoma
September 14th 2017Pembrolizumab has been approved by the European Commission for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy, or who are not eligible for cisplatin-containing chemotherapy.
Updated Results Show Encouraging PFS Benefit for Indoximod Plus Pembrolizumab in Melanoma
September 13th 2017An overall response rate of 61% was induced by adding the IDO inhibitor indoximod to pembrolizumab in patients with advanced melanoma, according to updated results presented at the International Cancer Immunotherapy Conference in Frankfurt/Mainz, Germany.
FDA Extends Decision Deadline on Trastuzumab Biosimilar MYL-1401O
September 1st 2017The decision deadline on a biologics license application (BLA) for MYL-1401O, a trastuzumab (Herceptin) biosimilar co-developed by Mylan and Biocon, has been extended by 3 months, the FDA has announced. Under the new timeframe, a final decision is expected on or before December 3, 2017.
sNDA for Carfilzomib Label Update in Myeloma Accepted by FDA
August 31st 2017A supplemental new drug application seeking to add overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib (Kyprolis) for use in patients with relapsed or refractory multiple myeloma has been accepted by the FDA.
Frontline Fulvestrant Receives FDA Approval for HR-Positive/HER2-Negative Breast Cancer
August 28th 2017Fulvestrant (Faslodex) has been approved by the FDA for use in hormone receptor-positive, HER2-negative locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.
Frontline Ribociclib Receives European Approval for HR+/HER2- Breast Cancer
August 24th 2017The CDK 4/6 inhibitor ribociclib (Kisqali) has been approved by the European Commission for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor (HR)–positive, HER2-negative locally advanced or metastatic breast cancer.
Ibrutinib Approved by FDA for GVHD
August 2nd 2017Ibrutinib (Imbruvica) has been approved by the FDA for the treatment of adult patients with chronic graft versus host disease (cGVHD) following the failure of 1 or more lines of systemic therapy. The BTK inhibitor is now the first FDA-approved therapy for the treatment of cGVHD.
Nivolumab Approved by FDA for MSI-H or dMMR Colorectal Cancer
August 1st 2017Nivolumab (Opdivo) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Venetoclax Granted Breakthrough Therapy Designation by FDA for AML Subpopulation
July 31st 2017The FDA has granted breakthrough therapy designation to venetoclax (Venclexta) for use in combination with low dose cytarabine (LDAC) in treatment-naïve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.
Lutathera Receives EMA Panel's Support for Approval for GEP-NETs
July 24th 2017Lutathera (lutetium [<sup>177</sup>Lu] oxodotreotide) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with unresectable or metastatic, progressive, well-differentiated (grade 1 and grade 2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
EU Recommends Frontline Obinutuzumab for Approval in Follicular Lymphoma
July 24th 2017Obinutuzumab (Gazyvaro, EU; Gazyva, US) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the frontline setting for the treatment of patients with follicular lymphoma.
Subcutaneous Rituximab Approved by FDA for Blood Cancers
June 22nd 2017Subcutaneous rituximab has been approved by the FDA for the treatment of adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated CLL.
Third Daratumumab Triplet Approved by FDA for Multiple Myeloma
June 16th 2017Daratumumab has been approved by the FDA for use in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor and lenalidomide.