Jason M. Broderick

The FDA has approved a supplemental new drug application for the use of 180-mg tablets of brigatinib (Alunbrig) for the treatment of patients with non–small cell lung cancer.

A 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 (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.

Based 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.

The 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.

Based 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 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.

An 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.

The 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.

The FDA recently released a statement providing specific data from 2 phase III trials placed on hold in July investigating pembrolizumab (Keytruda) in multiple myeloma.

A 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.

Fulvestrant (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.

The 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.

Exelixis has submitted a supplemental New Drug Application to the FDA for the multikinase inhibitor cabozantinib as treatment for previously untreated patients with advanced renal cell carcinoma.

Ibrutinib (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 (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.

The 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 (lutetium [¹⁷⁷Lu] 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).

Obinutuzumab (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.

Ipilimumab (Yervoy) has been approved by the FDA for the treatment of patients aged ≥12 years with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.

Neratinib (Nerlynx) has been approved by the FDA for the extended adjuvant treatment of patients with early stage HER2-positive breast cancer following postoperative treatment with trastuzumab (Herceptin). 

A new drug application (NDA) for abemaciclib has been granted a priority review by the FDA as a treatment for patients with advanced hormone receptor (HR)­­–positive, HER2-negative breast cancer.

In patients with heavily pretreated metastatic triple-negative breast cancer, pembrolizumab showed durable antitumor activity, according to findings from cohort A of the phase II KEYNOTE-086 trial.

Subcutaneous 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.

A supplemental biologics license application for the use of denosumab for the prevention of skeletal-related events in patients with multiple myeloma has been accepted by the FDA.

Daratumumab 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.

The combination of the PD-L1 inhibitor avelumab with the VEGF inhibitor axitinib as a frontline regimen for advanced renal cell carcinoma induced a response rate of 58.2% in patients with advanced renal cell carcinoma.

When epacadostat, an IDO1 inhibitor, was combined with pembrolizumab (Keytruda), a PD-1 inhibitor, responses were seen in 35% of patients with advanced urothelial carcinoma, according to findings presented during the 2017 ASCO Annual Meeting.  

Combining the PD-1 inhibitor pembrolizumab (Keytruda) with the HDAC inhibitor entinostat demonstrated promising clinical activity and acceptable safety in patients with melanoma who were refractory to immune checkpoint inhibitors. 

The risk of disease progression or death was reduced by 45% with the addition of abemaciclib to fulvestrant compared with that of fulvestrant alone in patients with previously treated HR-positive/HER2-negative breast cancer, according to findings presented during the 2017 ASCO Annual Meeting.