Silas Inman

The FDA has assigned a priority review designation to bevacizumab (Avastin) in combination with chemotherapy for patients with recurrent platinum-resistant ovarian cancer.

The somatostatin analog lanreotide (Somatuline Depot) significantly prolonged progression-free survival (PFS) compared with placebo for patients with metastatic gastroenteropancreatic NETs.

The FDA has assigned a priority review designation to bevacizumab (Avastin) plus chemotherapy as a treatment for patients with persistent, recurrent, or metastatic cervical cancer.

A phase III study comparing trametinib (Mekinist) plus dabrafenib (Tafinlar) with single-agent vemurafenib (Zelboraf) has been stopped early following a positive interim analysis.

The combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib significantly improved progression-free survival (PFS) compared with vemurafenib alone for patients with untreated BRAFV600-mutated advanced melanoma.

The investigational CD19-targeted chimeric antigen receptor (CAR) therapy CTL019 has received a breakthrough therapy designation from the FDA as a potential treatment for pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL).

The PD-1 inhibitor nivolumab and the second-generation ALK inhibitor alectinib have each gained their first approvals as treatments for patients in Japan.

Second-line treatment with MM-398 plus 5-FU and leucovorin extended OS, PFS, and ORR compared with 5-FU and leucovorin alone for patients with metastatic pancreatic cancer.

The FDA’s ODAC voted 11-2 against the accelerated approval of the PARP inhibitor olaparib as a maintenance therapy for women with platinum-sensitive relapsed ovarian cancer with germline BRCA mutations.

Frontline treatment with the anti-PD-1 agent nivolumab significantly extended overall survival (OS) when compared with dacarbazine for patients with metastatic or unresectable melanoma.

SAR650984 demonstrated encouraging efficacy as a monotherapy and in combination with dexamethasone and lenalidomide without reaching a maximum tolerated dose in patients with heavily pretreated multiple myeloma.

The novel agents idelalisib and ABT-199 in combination with rituximab have demonstrated impressive activity with manageable toxicity for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

The intratumoral injection talimogene laherparepvec (T-VEC) demonstrated promise in combinations and utility as a monotherapy in certain subsets of patients with unresectable melanoma.

Treatment with single-agent ibrutinib (Imbruvica) dramatically increased progression-free survival (PFS) by nearly 80% and significantly extended overall survival (OS) by 57% compared with ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Nivolumab and elotuzumab have each been granted breakthrough therapy designations by the FDA for the treatment of two types of blood cancers.

The ASCO clinical practice guideline now recommends treatment with adjuvant tamoxifen for 10 years in women with stage I-III hormone receptor (HR)-positive breast cancer.

The FDA has approved panitumumab (Vectibix) in combination with chemotherapy as a frontline treatment for patients with <em>KRAS</em> wild-type metastatic colorectal cancer (mCRC), based on findings from two phase III clinical trials.

The EGFR inhibitor CO-1686 has received a breakthrough therapy designation from the FDA for its potential as a treatment for patients with metastatic T790M mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of EGFR-targeted therapy.

A phase III study exploring the chemotherapy regimen DHAP plus ofatumumab failed to meet its primary endpoint of prolongation in PFS when compared with DHAP plus rituximab for patients with relapsed or refractory DLBCL.

The highly selective EGFR inhibitor AZD9291 demonstrated an ORR of 64% without inducing dose-limiting toxicities in patients with metastatic NSCLC who harbor an acquired EGFR T790M resistance mutation.

Treatment with the investigational oral agent TAS-102 significantly improved overall survival (OS) in a phase III trial for patients with heavily pretreated metastatic colorectal cancer (mCRC).

The combination of vemurafenib with the investigational MEK inhibitor cobimetinib demonstrated a 13.7-month median PFS and an ORR of 87% in treatment-naïve patients with BRAFV600 mutation-positive metastatic melanoma.

The FDA has assigned a priority review designation to the PD-1 inhibitor pembrolizumab (MK-3475) as a treatment for patients with unresectable or metastatic melanoma following progression on ipilimumab.

The addition of the investigational agent MM-398 (PEP02) to standard second-line chemotherapy significantly improved overall survival (OS) in a phase III trial for patients with metastatic pancreatic cancer.

The FDA has granted an accelerated approval to ceritinib (Zykadia; LDK378) as a treatment for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) following treatment with crizotinib.

The combination of custirsen (OGX-011) with docetaxel and prednisone failed to significantly extend survival as a first-line treatment for men with mCRPC.

The FDA has approved the anti-IL-6 chimeric monoclonal antibody siltuximab (Sylvant) as a treatment for HIV- and HHV-8-negative patients with multicentric Castleman’s disease (MCD).

The FDA has approved ramucirumab as a treatment for patients with unresectable gastric cancer or GEJ adenocarcinoma following fluoropyrimidine- or platinum-containing therapy, based on a significant extension in overall survival (OS).

Talimogene laherparepvec (T-VEC) significantly improved durable response rates (DRR) but failed to extend overall survival (OS) in patients with advanced melanoma.