News

In an interview with&nbsp;<em>Targeted Oncology</em>,&nbsp;Naveen Pemmaraju, MD, discussed the results from the phase I/II trial of single-agent tagraxofusp used to treat patients with R/R myelofibrosis and&nbsp;examined novel agents and combination regimens that are being studied to potentially treat this patient population.<br /> <br /> &nbsp;

An ongoing phase IIa clinical trial has demonstrated the safety and efficacy of milciclib maleate at 6 months in patients with unresectable or metastatic hepatocellular carcinoma who were resistant or intolerant to sorafenib.

In an interview with&nbsp;Targeted Oncology, Amir A.&nbsp;Jazaeri, MD,&nbsp;discussed the role of LN-145 in cervical cancer. He also highlighted next steps for this treatment approach and the promise of TIL therapy in cervical cancer, as well as other tumor types.

The FDA has granted a fast track designation to magrolimab for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome.

The FDA has granted neratinib with an orphan drug designation for the treatment of patients with breast cancer&ndash;related brain metastases.

The FDA has granted nirogacestat, an investigational gamma-secretase inhibitor, with a breakthrough therapy designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

A small retrospective study has found that patients who had differentiated thyroid cancer with bone metastasis and received radioiodine&nbsp;treatment in combination with one or more non-¹³¹I direct and systemic treatments experienced increased overall survival compared with patients who received only&nbsp;¹³¹I treatment.

Here&#39;s a look back on the FDA happenings for the month of August 2019, including FDA approvals, priority reviews, and breakthrough designations.

The review period has been extended by the FDA for a&nbsp;supplemental biologics license application for atezolizumab as a frontline treatment for patients with&nbsp;metastatic nonsquamous non&ndash;small cell lung cancer who do not have <em>EGFR</em> or <em>ALK</em> aberrations, in combination with&nbsp;carboplatin and nab-paclitaxel.

In an interview with&nbsp;Targeted Oncology, Shailender Bhatia, MD, highlighted the key takeaways from the 5 abstracts he found most significant at the 2019 ASCO meeting for the treatment of patients with melanoma.

In an interview with&nbsp;Targeted Oncology, Evert F.S. van Velsen, MD, MSc, discussed the evaluation of the 2015 ATA Risk Stratification in patients with DTC, including patients with PTC and FTC. He also highlighted challenges in treating patients that have been defined as high-risk for recurrence.

In an interview with <em>Targeted Oncology</em>, Gregorz S. Nowakowski, MD explained the details of the ECOG-ARIN 1412 trial and how the positive results related to patients with DLBCL will further improve outcomes for patients with all lymphoma types.

The addition of ixazomib to a combination of mitoxantrone, etoposide, and cytarabine demonstrated a promising rate of responses among patients with relapsed or refractory acute myeloid leukemia, according to the results of a phase I/II trial.

In an interview with&nbsp;Targeted Oncology, Sattva S. Neelapu, MD, discussed the evolving role for CAR T-cell therapy in patients with B-cell lymphomas. He also highlighted the toxicities commonly associated with these therapies and how physicians can treat these AEs as they arise.

The combination of atezolizumab and nab-paclitaxel has been approved by the European Commission as a frontline treatment for adult patients with unresectable, locally advanced, or metastatic PD-L1&ndash;positive triple-negative breast cancer, a result of the positive outcomes in the phase III IMpassion130 trial.

In an interview with <em>Targeted Oncology</em>, Michael Atkins, MD, discussed the latest follow-up data from the combination of nivolumab and ipilimumab across 2 trials and next steps in the research with this combination for patients with advanced melanoma.

The FDA has drafted new industry recommendations for sponsors to encourage male inclusion in clinical trials for breast cancer.<br /> &nbsp;

During a&nbsp;Targeted Oncology&nbsp;case-based peer perspectives presentation, Ajai Chari, MD, discussed with a group of physicians the treatment options available to patients with relapsed multiple myeloma. Chari explained the various treatment options and the supporting data based around a case scenario of a patient with multiple myeloma who relapses.

Findings from a phase II study in patients with small cell lung cancer suggested tumor immune phenotypes can be predictive of response to immune checkpoint blockade. Responses to the combination of durvalumab plus olaparib were observed in all patients where tumors had an inflamed phenotype.

In an interview with&nbsp;Targeted Oncology, Martin E. Gutierrez, MD, discussed the findings from the first-in-human phase I study investigating H3B-6527 in patients with HCC and ICC. He also highlighted the potential role for combination therapy with H3B-6527 and the next steps planned for subsequent phase II and III trials in HCC and ICC.

In an interview with <em>Targeted Oncology</em>, Shilpa Gupta, MD, discussed the results of the phase I/Ib trial of enzalutamide and gemcitabine and cisplatin in&nbsp;metastatic bladder cancer and defining platinum ineligibility in patients with metastatic urothelial cancer.

PD-L1 positivity in patients with medullary thyroid cancer is associated with more aggressive clinicopathological features and predictive of structural and biochemical recurrences, according to the results of a retrospective Chinese study.

In an interview with <em>Targeted Oncology,</em> Carol Mangione, MD, MSPH, a co-author on the USPSTF Recommendation Statement, gave insight&nbsp;into the specifics of the recommendations and how the Task Force hopes these suggestions will impact patient outcomes.<br /> &nbsp;

The addition of carboplatin and pemetrexed to therapy with gefitinib in patients with non&ndash;small cell lung cancer and an <em>EGFR</em>-sensitizing mutation had a statistically significant effect on progression-free survival and overall survival and represents a new therapy option for these patients.

A dose-finding phase Ib study successfully evaluated a combined regimen of oral ruxolitinib and buparlisib in adult patients with intermediate- or high-risk primary or secondary myelofibrosis for safety and efficacy.&nbsp;

John L. Marshall, MD, spoke with a group of physicians during a&nbsp;Targeted Oncology&nbsp;live case-based peer perspectives discussion on the different classes of agents available to treat patients with gastrointestinal cancers.

In an interview with <em>Targeted Oncology</em>, McCloskey discussed current treatment options for patients with myelofibrosis as well as further options in development in clinical trials. McCloskey recommended that community oncologists partner with specialists to improve the prognosis for these patients until new agents are approved, and for referrals to clinical trials for further research for this patient population.

Florida Cancer Specialists &amp; Research Institute has announced an oncology-focused initiative with Cigna as a part of the Cigna Collaborative Care. The Cigna Oncology Focus program's main goal is to provide quality care and contain costs for people with cancer. It also uses incentives to encourage healthcare professionals to improve affordability, as well as patients health and overall experience.

Belantamab mafodotin, an investigational antibody&ndash;drug conjugate, demonstrated a clinically meaningful overall response rate among patients with relapsed multiple myeloma in early results from the DREAMM-2 trial, according to a press release from GlaxoSmithKline. This met the primary endpoint of the pivotal phase II trial.

In an interview with&nbsp;<em>Targeted Oncology</em>, Ruben Mesa, MD, discussed the results from the reanalysis of the JAKARTA-2 trial that led to the approval of fedratinib in patients with MF. He also highlighted the role of the FREEDOM study that is currently enrolling patients with MF for treatment with fedratinib.