News

The FDA has granted a fast track designation to navicixizumab for the treatment of patients with high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received ≥3 prior therapies and/or prior bevacizumab.

In the phase III INVICTUS trial, ripretinib, a novel KIT and PDGFRA inhibitor, demonstrated a dramatic improvement in progression-free survival compared with placebo in heavily pretreated patients with heavily advanced gastrointestinal stromal tumors, according to data presented at the 2019 ESMO Congress.

In a randomized trial, treatment with MEK inhibitor trametinib showed significant improvement in progression-free survival and overall survival in patients with recurrent, low-grade serous ovarian cancer.<br /> &nbsp;

The multikinase inhibitor entrectinib induced frequent and durable responses, which often deepened over time, in patients with <em>ROS1</em>-positive and&nbsp;<em>NTRK</em>-positive non&ndash;small cell lung cancer, according to an integrated analysis of 3 clinical trials.

In the phase III CASPIAN study, durvalumab added to etoposide and platinum-based chemotherapy delayed the development of new lesions and improved patient-reported outcomes compared to etoposide and platinum-based therapy alone in untreated patients with extensive-stage small cell lung cancer.

The FDA has granted duvelisib with an orphan drug designation for the treatment of patients with T-cell lymphoma, according to a press release from Verastem Oncology, the company developing duvelisib.<br /> &nbsp;

Patients with high-grade serous ovarian cancer experienced a 32% reduction in the risk of progression or death with frontline combination veliparib plus carboplatin and paclitaxel followed by veliparib maintenance, according to the data from the phase III VELIA trial presented at the 2019 ESMO Congress, and simultaneously published in the&nbsp;New England Journal of Medicine.

The FDA has granted cobimetinib, a MEK inhibitor, with a breakthrough therapy designation for the treatment of adult patients with histiocytic neoplasms who do not harbor a <em>BRAF</em> V600 mutation.

The FDA has granted a breakthrough therapy designation to niraparib for the treatment of patients with <em>BRCA1/2</em>-mutated metastatic castration-resistant prostate cancer who have previously received taxane chemotherapy and androgen receptor&ndash;targeted therapy.

In an interview with&nbsp;<em>Targeted Oncology</em>, Gregory Gores, MD explained the role of molecular therapy and the use of genetic testing to guide treatment of iCCA.

The FDA has approved a labeling supplement for neratinib for the extended adjuvant treatment of patients with HER2-positive early-stage breast cancer. The labeling supplement adds safety information based on interim findings from the phase II CONTROL trial, which investigated the use of preventive strategies to reduce the incidence and severity of neratinib-associated diarrhea.

In an interview with&nbsp;<em>Targeted Oncology</em>, Nicholas J. Vogelzang, MD, FACP, FASCO, explained the need for updates to clinical trial criteria to make checkpoint inhibition more widely available to patients with metastatic bladder cancer.

An open-label phase II trial of regorafenib given continuously at a reduced dose of 100 mg daily to patients with refractory gastrointestinal stromal tumors found that nearly two-thirds of patients achieved disease control lasting for at least 12 weeks.<br /> &nbsp;

Due to treatment benefit observed in pediatric patients with acute lymphoblastic leukemia,&nbsp;2 clinical trials investigating blinatumomab (Blincyto) versus chemotherapy were stopped early, according to the drug developer Amgen.

In September 2019, the FDA approved new treatment options for patients with endometrial carcinoma, prostate cancer, and multiple myeloma. The FDA also expanded the indication for the Cologuard noninvasive screening test for colorectal cancer. During the month there were 2 breakthrough therapy designations, 2 fast track designations, 1 orphan drug designation, and 1 priority review granted.

The FDA has granted a fast track designation to imetelstat for the treatment of adult patients with relapsed or refractory myelofibrosis who have intermediate-2 or high-risk disease. This designation is inclusive of patients with primary MF or those who developed MF after thrombocythemia or polycythemia vera, according to a press release from Geron Corporation, the developer of the drug.<br /> &nbsp;

Umbralisib and ublituximab in combination with pembrolizumab was well tolerated among patients with relapsed/refractory chronic lymphocytic leukemia and Richter&rsquo;s transformation, according to a phase I/II trial presented at the 18th International Workshop on CLL. Responses were durable in high-risk patients who are BTK-refractory, including 2 complete responses in patients with RT.

In an interview with&nbsp;Targeted Oncology, Tetsuya Mitsudomi, MD, summarized the major areas under investigation for the treatment of patients with lung cancer and highlighted key findings from the updated 5-year data of the KEYNOTE-001 trial.

Best practices for targeting colon cancer was the topic of discussion during a&nbsp;Targeted Oncology live case-based peer perspectives presentation led by John H. Strickler, MD.

The combination of daratumumab plus bortezomib, thalidomide, and dexamethasone (VTD) has been approved by the FDA for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.

The investigational agent UGN-101 induced a complete response in 59% of patients with low-grade upper tract urothelial cancer in the phase III OLYMPUS trial, according to findings from a final analysis of the pivotal trial.&nbsp;

In an interview with&nbsp;Targeted Oncology, Ezzat Elhassadi, MD, discussed the results from this analysis and how the presence of a&nbsp;TP53&nbsp;mutation can impact the survival of patients with MCL. He also highlighted the remaining challenges in this space and how these challenges can be overcome.

In an interview with&nbsp;<em>Targeted Oncology</em>, Marcelo C. Pasquini, MD, discussed the importance of obtaining real-world data and establishing registries for collecting patient outcomes, and how real-world data compare with data from pivotal trials. He also explained the challenges with accessibility to CAR T-cell therapies.

The PI3K-delta inhibitor umbralisib demonstrated a favorable toxicity profile as treatment for patients with chronic lymphocytic leukemia who have become intolerant to a prior kinase inhibitor, of either BTK or PI3K inhibition, according to results from a phase II study presented at the 18th International Workshop on CLL.

In an interview with <em>Targeted Oncology</em>, Dean A. Fennell, MD, PhD, explained the need for the MIST trial and personalized treatment for patients with mesothelioma.

In an interview with&nbsp;<em>Targeted Oncology</em>, Srdan Verstovsek, MD, PhD, discussed the treatment of MPNs in the community setting and how the field can improve. He also encouraged community oncologist to incorporate quality-of-life measurements and prognostic scoring systems when treating these patients.<br /> &nbsp;

The FDA has expanded the indication for the Cologuard noninvasive screening test for colorectal cancer to include eligible patients with an average risk of developing colorectal cancer who are between the ages of 45 and 49.

In an interview with Targeted Oncology, Stacey Stein, MD, discussed what attendees can expect to learn about at the 2019 ISGIO Annual Conference in terms of the treatment landscape for CRC. She also highlighted some of the recent advancements that physicians treating CRC should be aware of heading into this meeting.

The FDA has granted a fast track designation to abexinostat for the treatment of patients with relapsed or refractory follicular lymphoma in the fourth-line setting.<br /> &nbsp;

Certain patients with BRAF non-V600-mutant, RAS-dependent metastatic colorectal cancer may be sensitive to anti-EGFR therapy, according to the results of a&nbsp;a multicenter pooled analysis recently published in Clinical Cancer Research.&nbsp;The analysis suggested that those with&nbsp;RAS<em>-</em>dependent tumors were more likely to respond to anti-EGFR therapy than those with&nbsp;RAS-independent tumors.&nbsp;