Jason M. Broderick

Neratinib has been recommended for approval by the FDA’s Oncologic Drugs Advisory Committee in a 12-4 vote for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab.

Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient solid tumors.

Ceritinib (Zykadia) has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use for the treatment of patients with ALK-positive, metastatic non–small cell lung cancer.

Pembrolizumab (Keytruda) has been approved by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Copanlisib has been granted a priority review designation by the FDA as a treatment for patients with relapsed/refractory follicular lymphoma who have received at 2 least prior therapies.

Entrectinib has been granted breakthrough therapy designation by the FDA&nbsp;for use as a treatment for adult and pediatric patients with <em>NTRK</em>-positive, locally advanced or metastatic solid tumors.

The BRAF inhibitor encorafenib combined with the MEK inhibitor binimetinib reduced the risk of disease progression or death by 23% compared with single-agent encorafenib for patients with&nbsp;<em>BRAF</em>-mutant melanoma.

Pembrolizumab (Keytruda) has been granted an accelerated approval&nbsp;by the FDA for use in combination with pemetrexed plus carboplatin as a frontline treatment for patients with metastatic or advanced nonsquamous non&ndash;small cell lung cancer, regardless of PD-L1 expression.

Atezolizumab failed to meet the primary endpoint of improving overall survival in the second-line setting for patients with locally advanced or metastatic urothelial carcinoma.

An accelerated approval for the PD-L1 inhibitor avelumab (Bavencio) has been granted by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Pembrolizumab has been approved by the European Commission for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.

The PD-L1 inhibitor durvalumab has been granted an accelerated approval by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Daratumumab has been approved by the European Commission for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of patients with multiple myeloma following at least 1 prior therapy.

Brigatinib has been granted an accelerated approval by the FDA as a treatment for patients with metastatic <em>ALK</em>-positive non&ndash;small cell lung cancer who are resistant to prior crizotinib.

Midostaurin (Rydapt) has been approved by the FDA for the treatment of adult patients with newly diagnosed <em>FLT3</em>-positive acute myeloid leukemia (AML) in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.

Regorafenib has been approved by the FDA as a second-line treatment for patients with unresectable hepatocellular carcinoma who have previously received sorafenib.

The addition of abemaciclib to letrozole or anastrozole improved progression-free survival over either aromatase inhibitor alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 3 study.

Veliparib fell short of meeting the primary endpoint&nbsp;in a phase III non&ndash;small cell lung cancer trial and a triple-negative breast cancer trial.

Tisagenlecleucel-T has been granted a breakthrough therapy designation by the FDA&nbsp;for use as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma after the failure of at least 2 prior therapies.

Atezolizumab (Tecentriq) has been granted an accelerated approval by the FDA as a frontline treatment for cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.

An Oncologic Drugs Advisory Committee hearing has been scheduled by the FDA for May 24, 2017, to discuss a new drug application for neratinib as a treatment for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab.

According to findings from the phase III ALEX trial, alectinib reduced the risk of disease progression or death compared with crizotinib as a frontline treatment for patients with <em>ALK</em>-positive non&ndash;small cell lung cancer.&nbsp;

Combining the IDO inhibitor indoximod with pembrolizumab led to an overall response rate of 52% in patients with advanced melanoma.

FDA approval is being sought for the use of denosumab for the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.

According to results of the phase II JAVELIN Merkel 200 study, the PD-L1 inhibitor avelumab (Bavencio) induced an objective response rate (ORR) of 33% in patients with advanced Merkel cell carcinoma, including 2 additional complete responses (CR) since the primary analysis.

Palbociclib (Ibrance) has been granted a full approval by the FDA for use in combination with letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer.

The FDA has granted a priority review to a supplemental biologics license application (sBLA) supporting the conversion of the accelerated approval of blinatumomab (Blincyto) to a full approval as a treatment for patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Subcutaneous rituximab has received the FDA&rsquo;s Oncologic Drugs Advisory Committee (ODAC) unanimous (11-0) recommended approval for the treatment of patients with certain blood cancers.

A new drug application (NDA) for olaparib (Lynparza) as a maintenance therapy in relapsed patients with platinum-sensitive ovarian cancer has been granted a priority review by the FDA.

The PARP inhibitor niraparib (Zejula) has been approved by the FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.