Silas Inman

Ibrutinib (Imbruvica) and idelalisib (Zydelig) have become standard of care treatments for patients with relapsed or high-risk chronic lymphocytic leukemia, with ongoing studies in progress to move ibrutinib into the frontline setting.

Treatment with vemurafenib (Zelboraf) demonstrated an objective response rate of up to 38.5% for patients with radioactive iodine-refractory BRAF V600E-mutant papillary thyroid cancer who were multikinase inhibitor-naive.

A phase I/II study will explore the delta-like protein 3-targeted antibody-drug conjugate rovalpituzumab tesirine (Rova-T) with the PD-1 inhibitor nivolumab (Opdivo) alone or in combination with the CTLA-4 inhibitor ipilimumab (Yervoy) for patients with relapsed extensive-stage small cell lung cancer.

The Committee for Medicinal Products for Human Use has recommended the approval of pegylated liposomal irinotecan (Onivyde) in combination with fluorouracil and leucovorin for patients with metastatic pancreatic adenocarcinoma following progression on a gemcitabine-based therapy.

The Committee for Medicinal Products for Human Use has adopted a positive option for crizotinib (Xalkori) as a treatment for adults with ROS1-positive advanced non–small cell lung cancer, suggesting an approval may be imminent.

The CHMP has recommended the approval of lenvatinib in combination with everolimus for patients with advanced renal cell carcinoma following one prior VEGF-targeted therapy.

A 5-year assessment showed that neratinib reduced the risk of invasive disease recurrence or death by 26% compared with placebo as extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab.

The biosimilar ABP 980 demonstrated similar pathologic complete response rates as the reference product trastuzumab (Herceptin) in a phase III study for patients with HER2-positive early breast cancer.

The treatment landscape for patients with chronic lymphocytic leukemia continues to evolve, as long-term data become available from pivotal studies that led to the FDA approvals for the BTK inhibitor ibrutinib (Imbruvica) and the PI3K inhibitor idelalisib (Zydelig).

The phase III AURA3 study has confirmed the benefits of osimertinib seen in earlier phase II studies for patients with EGFR T790M-mutant locally-advanced or metastatic non–small cell lung cancer following progression on a frontline EGFR TKI.

The FDA has granted a priority review designation to nivolumab as a treatment for patients with previously treated metastatic or recurrent squamous cell carcinoma of the head and neck.

The FDA has approved a smaller and lighter version of Optune for patients with glioblastoma multiforme.

After less than a week, the FDA has lifted a clinical hold placed on the phase II ROCKET study that is exploring the CAR T-cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

Treatment with aldoxorubicin failed to improve progression-free survival compared with investigator's choice of therapy for patients with advanced soft tissue sarcoma.

The FDA has placed a clinical hold on a phase II study exploring the CD19-targeted CAR-T cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

The European Commission has approved carfilzomib in combination with dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy.

Treatment with ARQ-087 demonstrated promising signs of clinical activity with a manageable safety profile for patients with FGFR2 fusion-positive advanced and/or metastatic intrahepatic cholangiocarcinoma.

A new drug application has been submitted for binimetinib as a potential treatment for patients with advanced NRAS-mutant metastatic melanoma.

The FDA has granted a breakthrough therapy designation to ibrutinib has a potential treatment for patients with chronic graft-versus-host-disease after failure of one or more lines of systemic therapy.

Maintenance therapy with niraparib improved progression-free survival compared with placebo for patients with recurrent ovarian cancer harboring a germline BRCA mutation or homologous recombination deficiency.

The FDA has granted an orphan drug designation to the STAT3 targeted agent napabucasin as a treatment for patients with gastric and gastroesophageal junction cancer.

Second-line treatment with regorafenib (Stivarga) improved overall survival by 2.8 months compared with placebo for patients with unresectable hepatocellular carcinoma who progressed on sorafenib (Nexavar).

A marketing authorization application has been submitted to the European Medicines Agency for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab.

The FDA has granted a priority review designation to Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors.

NICE has approved the combination of nivolumab and ipilimumab for patients with metastatic melanoma, which allows the combination to be used within NHS.

Rolling submission of a new drug application for brigatinib (AP26113) has been initiated for patients with advanced ALK-positive non–small cell lung cancer who are resistant to prior crizotinib (Xalkori).

Single-agent duvelisib demonstrated an overall response rate of 46% for patients with indolent non-Hodgkin lymphoma, which successfully met the primary endpoint for the phase II DYNAMO study but not investor expectations.

Frontline treatment with the CD33-directed antibody-drug conjugate vadastuximab talirine plus a hypomethylating agent induced deep and durable remissions for older patients with acute myeloid leukemia.

Ibrutinib continued to demonstrate impressive antitumor activity in a pooled analysis of 243 patients with deletion 17p chronic lymphocytic leukemia.

Pembrolizumab demonstrated an objective response rate of 18% in data from two clinical trials exploring the PD-1 inhibitor as a treatment for patients with pretreated recurrent or metastatic head and neck squamous cell carcinoma.