Silas Inman

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.

The antibody-drug conjugate T-DM1 (ado-trastuzumab emtansine; Kadcyla) will have an impact on the entire spectrum of care for patients with metastatic HER2-positive breast cancer, resulting in a greater emphasis on patient selection protocols and testing.

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

The investigational CD19-targeted CAR therapy CTL019 has received a breakthrough therapy designation from the FDA as a potential treatment for pediatric and adult patients with relapsed/refractory 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.

Treatment with the oral nucleoside TAS-102 significantly extended OS and PFS for patients with metastatic colorectal cancer refractory to standard therapies.

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 Oncologic Drugs Advisory Committee 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 when compared with dacarbazine for patients with metastatic or unresectable melanoma.

The FDA has issued a drug safety communication regarding the risk of intoxication with the intravenous ethanol-containing chemotherapy docetaxel.

A multitude of studies presented over the course of the past year have emphasized the importance of broader RAS mutational analyses outside of traditional KRAS testing for patients with metastatic colorectal cancer.

The frontline treatment of patients with Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML) continues to be debated as imatinib (Gleevec) rapidly approaches the end of its patent protection and next-generation agents continue to show efficacy in clinical trials.

The CD38-specific monoclonal antibody 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.

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

Treatment with single-agent ibrutinib dramatically increased PFS by nearly 80% and significantly extended OS by 57% compared with ofatumumab in patients with relapsed or refractory CLL.

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

The FDA has expanded the approval of panitumumab to include the frontline treatment of patients with KRAS wild-type mCRC in combination with chemotherapy.

CO-1686 has received a breakthrough therapy designation from the FDA for its potential as a treatment for patients with metastatic T790M mutation-positive 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.

Over the course of only a few days, two drugs that will be commercialized by Bristol-Myers Squibb (BMS), nivolumab and elotuzumab, have each been granted breakthrough therapy designations by the FDA for the treatment of two different types of blood cancers.

The highly selective EGFR inhibitor AZD9291 demonstrated an overall response rate 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 in a phase III trial for patients with heavily pretreated metastatic colorectal cancer.

The combination of the BRAF inhibitor vemurafenib with the investigational MEK inhibitor cobimetinib was safe and effective in treatment-naive 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 FDA has approved subcutaneous omacetaxine mepesuccinate injection for home administration in patients with chronic or accelerated phase CML who are resistant or intolerant to treatment with TKIs.

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

The FDA has approved the next-generation ALK inhibitor ceritinib as a treatment for ALK-positive patients with metastatic non-small cell lung cancer 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 metastatic castration-resistant prostate cancer

The FDA has approved the cobas HPV Test as a first-line screening tool for cervical cancer in women 25 and older, making it the first-ever approval for a diagnostic alternative to Pap smear.