News

Merck has announced that enrollment for the phase III KEYNOTE-183 and KEYNOTE-185 multiple myeloma trials has been postponed due to deaths in patients treated with pembrolizumab.

According to early results from the phase III APHINITY trial, the addition of pertuzumab (Perjeta) to standard postoperative trastuzumab (Herceptin) therapy for patients with HER2-positive early breast cancer slightly improved the rate of recurrence overall but had a greater benefit for individuals with higher-risk disease.

Six to 9 months of treatment with neoadjuvant imatinib (Gleevec) was a promising treatment for patients with large gastric gastrointestinal stromal tumors (GIST), according to the results of a small multinational study in Asian patients.

Christophe Massard, MD, PhD, discusses ongoing clinical trials evaluating durvalumab, toxicities to be aware of with the agent, and the impact the approval has had in the field.

A retrospective, multicenter study of 1207 women treated for non-metastatic breast cancer who then became pregnant showed that these survivors faced no greater risk of recurrence or death than their counterparts who underwent treatment but did not become pregnant.

Drug manufacturer XBiotech has cancelled the phase III XCITE study of MABp1 (Hutruo; formerly Xilonix) in patients with advanced colorectal cancer, following a second prospectively planned, unblinded analysis.

Findings from a recent pilot study done at the University of Pittsburgh Medical Center showed a potential link between e-cigarette use and bladder cancer.

Patients with refractory advanced melanoma who had received prior treatment with a checkpoint inhibitor demonstrated promising overall response rate and duration of response in a phase II study involving the antibody-drug conjugate glembatumumab vedotin.

In patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase, a 400-mg dose of bosutinib (Bosulif) was associated with higher rates of major molecular response (MMR) and complete cytogenetic response (CCyR) than imatinib (Gleevec).

Norman (Ned) E. Sharpless, MD, has been named director of the National Cancer Institute (NCI) by President Donald Trump.

Adding the PD-1 inhibitor pembrolizumab (Keytruda) to standard neoadjuvant chemotherapy tripled the pathologic complete response (pCR) rate in multiple subtypes of HER2-negative breast cancer, according to results from the ongoing phase II I-SPY-2 clinical research program presented during the 2017 ASCO Annual Meeting.

The FDA has scheduled a public hearing of its Oncologic Drugs Advisory Committee (ODAC) to address a biologics license application (BLA) for tisagenlecleucel-T (CTL019) for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The hearing is planned for July 12, 2017.

More than 40% of patients with melanoma brain metastases achieved objective intracranial responses to combination treatment with nivolumab (Opdivo) and ipilimumab (Yervoy), results of a randomized phase II trial showed.

IBM’s Watson for Oncology, which interprets patient data and provides treatment guidance, and Cota, which provides real-world patient data for large cohort analysis and individualized treatment guidance, will be combined in a pilot study with Hackensack Meridian Health to help oncologists make improved evidence- and outcomes-based clinical decisions for their cancer patients.

It’s been a busy month at the FDA. Here’s a look back at all the news in the oncology field to come out of the FDA during the month of May.

A new drug application from Jazz Pharmaceuticals has been accepted by the FDA for a novel CPX-351 injection (Vyxeos) for the treatment of acute myeloid leukemia.

Sunitinib (Sutent) has been granted a priority review designation by the FDA for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.

The addition of ramucirumab to docetaxel led to a statistically significant improvement in progression-free survival versus docetaxel alone in previously treated patients with locally advanced or unresectable or metastatic urothelial carcinoma.

Edward Messing, MD, discusses his paper which found patients who underwent chemotherapy following transurethral resection of bladder tumor were less likely to have tumor recurrence.

Brian Wolpin, MD, MPH, has been named director of the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute.

Ceritinib (Zykadia) has been approved by the FDA for the treatment of patients with <em>ALK</em>-positive, metastatic non&ndash;small cell lung cancer.

Axicabtagene ciloleucel (KTE-C19; axi-cel) has been granted a priority review by the FDA for transplant-ineligible patients with relapsed or refractory non-Hodgkin lymphoma.

Nivolumab (Opdivo) has been granted a priority review designation by the FDA for use as a treatment for patients with hepatocellular carcinoma following prior sorafenib (Nexavar).

The approval of a&nbsp;biologics license application (BLA) for&nbsp;epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira, was recommended for approval by the&nbsp;FDA&rsquo;s Oncologic Drugs Committee voted (ODAC) 14-1 today.&nbsp;

Pembrolizumab (Keytruda) has been granted a priority review by the FDA for the treatment of patients who have undergone at least 2 courses of chemotherapy for recurrent or advanced gastric or gastroesophageal junction adenocarcinoma.

NewYork-Presbyterian has established the William Rhodes and Louise Tilzer-Rhodes Center for Glioblastoma, to be led by physicians from Columbia University Medical Center and Weill Cornell Medicine.

Durvalumab (Imfinzi) showed a modest but encouraging clinical benefit in patients with <em>EGFR</em>-mutant or <em>ALK</em>-positive non&ndash;small cell lung cancer with high tumor PD-L1 expression of &ge;25% in the third-line setting or beyond.

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

Arjun&nbsp;V. Balar, MD, discusses&nbsp;the impact of the approval of pembrolizumab and other immunotherapy agents in urothelial carcinoma, as well as the next steps with these treatments.

Bevacizumab demonstrated superior progression-free survival and a trend toward improved overall survival (OS) in patients with proliferative or mesenchymal ovarian tumors compared with patients with immunoreactive or differentiated tumors.