News

The indication for palbociclib capsules in combination with endocrine therapy now includes the treatment of male patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer after being expanded by the FDA.

Entinostat in combination with pembrolizumab induced responses in patients with recurrent or metastatic melanoma who have progressed on or after prior anti–PD-1 therapy, according to results of a phase II trial.

During a <em>Targeted Oncology </em>live case-based peer perspectives program, Christopher Maisel, MD, recently discussed the treatment options and considerations he makes when treating patients with multiple myeloma.

A look back at all the&nbsp;FDA news&nbsp;that happened in March 2019, including several new approvals, a clinical hold, an orphan drug designation, and more.

Overall survival was significantly improved in&nbsp;patients with relapsed/refractory <em>FLT3</em> mutation&ndash;positive acute myeloid leukemia who were treated with the FLT3 inhibitor gilteritinib, according to&nbsp;updated findings presented during the 2019 AACR Annual Meeting.

The FDA has granted a breakthrough therapy designation to the investigational agent selumetinib for the treatment of pediatric patients &ge;3 years old with symptomatic and/or progressive, inoperable neurofibromatosis type 1

Five of 9 patients with large triple-negative breast tumors treated with the viral oncolytic talimogene laherparepvec plus neoadjuvant chemotherapy achieved&nbsp;pathologic complete response, according to findings from a preliminary trial.

In findings presented during the 2019 AACR Annual Meeting, safety and efficacy was seen with CAR T cells targeting&nbsp;mesothelin-expressing tumors&nbsp;in a preliminary clinical evaluation in patients with malignant pleural disease.

An immunotherapy combination led to a response rate of 44% in patients with high-grade neuroendocrine carcinoma, according to the results of a phase II trial presented at the 2019 AACR Annual Meeting. Nivolumab in combination with ipilimumab was also well tolerated among patients, the results of the DART study showed.&nbsp;

In phase I findings presented during the 2019 AACR Annual Meeting, HER2-directed CAR T-cell therapy and lymphodepletion chemotherapy was found to be safe and effective as a treatment for&nbsp;pediatric and adult patients with advanced HER2-positive sarcoma.

Ahead of the 2019 Annual Meeting, the American Association for Cancer Research announced the recipients of a number of scientific awards and lectureships. Honorees will be recognized for their achievements during the AACR Annual Meeting, which is being held March 29&ndash;April 3 in Atlanta, Georgia.

Gynecologic oncology experts reflect on some of the most significant data presented during the 2019 SGO Annual Meeting, which underscored how the field is moving toward a precision medicine approach.

Ali McBride, PharmD, MS, BCOP, began his term as the 2019&ndash;2020 President of the Association of Community Cancer Centers on March 22, 2019, during the 45th Annual Meeting and Cancer Center Business Summit. He succeeds Tom A. Gallo, MS, MDA, who served as president of ACCC for the 2018-2019 term.

Recently published data from a retrospective study suggest that patients with thyroid cancer who have T-cell lymphopenia are more likely to have aggressive tumors. Investigators believe this information can be used to identify potential therapeutic targets in these patients.

Investigational agent tinostamustine (EDO-S101), a first-in-class alkylating deacetylase inhibiting molecule, has been granted orphan drug designation by the FDA for the treatment of patients with T-cell prolymphocytic leukemia.

Radiation oncologist Jimmy J. Caudell, MD, PhD,discusses the role of radioactive iodine therapy in patients with DTC. He also highlights areas of research that may help determine the best treatment regimens and doses for select patients.

An analysis of the genotyping of tumor tissue samples from patients with hepatocellular carcinoma identified frequent alterations and potentially actionable mutations in cases of HCC, and helped to confirm the clinical utility of next-generation sequencing testing for matching patients to targeted therapies and immunotherapies.

A comprehensive effort to assess the prevalence of microsatellite instability in a large series of malignant thyroid tumors comprising all major histologic subtypes has found that the overall prevalence of MSI in follicular thyroid cancer is 2.5%. The study also found that MSI is either entirely absent or rare in other histology subtypes of thyroid carcinoma.

Michael A. Morse, MD, FACP, MHS,&nbsp;highlights the latest ongoing research in HCC and predicts what future treatment might look like in this field.

Positive findings have been seen with a novel antibody&ndash;drug conjugate in a pivotal trial for patients with advanced or metastatic urothelial cancer who have previously been treated with immunotherapy and chemotherapy, according to an announcement from the co-manufacturers Seattle Genetics and Astellas Pharma.

In an effort to enable healthcare providers and patients to make more informed medical decisions, the FDA has proposed amendments to key policies to modernize breast cancer screening and improve mammography services.

During a <em>Targeted Oncology</em> live case-based peer perspectives program, B. Douglas Smith, MD, discussed his clinical consideration for the management of acute myeloid leukemia. Smith explained his treatment decisions during the dinner event in 2 case scenarios of patients with AML.

The FDA has granted ivosidenib plus azacitidine a breakthrough therapy designation for the treatment of newly diagnosed patients with acute myeloid leukemia who harbor an <em>IDH1 </em>mutation and are &ge;75 years old or have comorbidities that would prevent them from receiving intensive induction chemotherapy.

According to new data, survivors of childhood cancer who have lived 5 or more years from their primary malignancy may be up to 30 times more likely to develop a skin malignancy compared with the general population.

Under the updated&nbsp;guideline from the National Comprehensive Cancer Network for the management of&nbsp;chronic myeloid leukemia,&nbsp;discontinuation of TKI therapy is considered safe with careful monitoring in adult patients with CML in the chronic phase&nbsp;who achieve and maintain a major molecular response.

A supplemental biologics license application has been submitted to the FDA for the potential approval of a new indication for daratumumab. The sBLA was for the combination of daratumumab plus bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.

A pivotal phase III INNOVATE-3 trial investigating the efficacy of tumor-treating fields (TTFields; Optune) combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer has been initiated, according to Novocure, the company developing the device.

Under the 2019 update to the&nbsp;National Comprehensive Cancer Network guidelines, the recommendation&nbsp;on the management of&nbsp;advanced clear cell renal cell carcinoma has undergone a major shift in defining the risk category used to define preferred and alternative first-line treatments.

Mario E. Lacouture, MD, has joined the Treatment Support Program of the National Community Oncology Dispensing Association as director of the medical advisory board.

Lurbinectedin (PM1183) monotherapy induced responses in patients with relapsed small cell lung cancer, achieving the primary endpoint of overall response rate in a single-arm phase II trial, according to an announcement from PharmaMar, the company developing lurbinectedin.