News

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;

Michael R. Migden, MD, spoke with a group of physicians during a <em>Targeted Oncology </em>live case-based peer perspectives discussion about responses in patients with cutaneous squamous cell carcinoma to immunotherapy treatment.

In an interview with <em>Targeted Oncology</em>,<em> </em>Prithviraj Bose, MD, reviewed his thoughts on identifying and treating progression in myelofibrosis, which he recently presented on during the 2019 SOHO Annual Meeting.&nbsp;&nbsp;

The American Oncology Network, LLC highlights its achievements while celebrating its first year of helping community oncologists.

In an interview with <em>Targeted Oncology</em>, Neil P. Shah, MD, PhD, discussed the latest advancements in the treatment landscape of chronic myeloid leukemia, including the introduction of tyrosine kinase inhibitors. He also addressed some of the challenges both oncologists and patients face in this space.<br /> &nbsp;

In an interview with <em>Targeted Oncology</em>, Jonathan Rosenberg, MD, discussed the ongoing study of durvalumab plus olaparib in patients with metastatic urothelial cancer and other studies that have lain the groundwork for this combination.

In an interview with <em>Targeted Oncology</em>, Michael A. Choti, MD, discussed what he&rsquo;s looking forward to at the 2019 ISGIO Annual Conference and why this meeting is so important to physicians in the field of GI oncology. He also highlighted the surgical approaches to treating patients with HCC from his own experiences as a surgical oncologist, as well as the challenges associated with these treatment options.

The phase III FeDeriCa trial found that a fixed-dose subcutaneous injection of pertuzumab and trastuzumab with hyaluronidase in combination with intravenous chemotherapy was pharmacokinetically noninferior&nbsp;to the standard IV infusions of the regimen in patients with HER2-positive breast cancer.<br /> &nbsp;

The FDA has approved a supplemental New Drug Application for apalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer.

In an interview with <em>Targeted Oncology</em>, Simon Rule, MD, gave an overview of the standard of care for MCL, which he recently presented at the 2019 SOHO Annual Meeting.

The FDA has granted an accelerated approval to the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced endometrial cancer who have disease progression following prior systemic therapy. The indication applies to patients who are not candidates for curative surgery or radiation and who have disease that is not microsatellite instability&ndash;high or mismatch repair deficient.

In an interview with&nbsp;<em>Targeted Oncology</em>, Raymond L. Chai, MD, discussed the latest treatment advancements for thyroid cancer that he has seen over the past few years and how he sees quality of life improving for patients with advanced subtypes of thyroid cancer. He also shared a personal message for oncologists in honor of Thyroid Cancer Awareness Month.

The combination of carfilzomib, dexamethasone, and daratumumab led to a 37% reduction in the risk of progression or death compared with carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma in the phase III CANDOR trial. According to a press release from Amgen, this met the primary endpoint of progression-free survival for the trial.

A matched retrospective comparison showed that progression-free survival&nbsp; in patients with advanced non-small cell lung cancer and actionable mutations was similar whether treatment went was guided with the use of tissue or circulating tumor DNA analysis with the Guardant360 assay.

The FDA has issued a warning for a rare, but severe, lung inflammation that could be caused by the use of CDK4/6 inhibition in patients with advanced breast cancers.&nbsp;The warning applies to treatment with palbociclib, ribociclib, and abemaciclib specifically, but warnings of the risk of lung inflammation have been approved to be added to the prescribing information for the entire class of CDK4/6 inhibitors.