News

Bemcentinib, a first-in-class AXL inhibitor, in combination with the PD-1 inhibitor pembrolizumab showed activity in patients with immunotherapy-naive advanced non–small cell lung cancer, according to findings from the phase II study presented at the 2019 World Conference on Lung Cancer.

Cristina Magi-Galluzzi, MD, PhD, discussed the role of pathologists in the diagnosis and treatment decision for patients with prostate, bladder, and renal cancers. 

A statistically significant improvement in overall survival was demonstrated with durvalumab, a PD-L1 inhibitor, combined with chemotherapy in patients with previously untreated extensive-stage small cell lung cancer, according to findings from the phase III CASPIAN trial, presented at the 2019 World Conference on Lung Cancer.

In an interview with Targeted Oncology, John Bartlett, MD, explained the standardized cancer testing project, its relevance, and how it could be used to improve the treatment of patients with pancreatic, prostate, breast cancer. 

The FDA has granted a fast track designation to AMG 510 for the treatment of patients with previously treated metastatic non&ndash;small cell lung cancer harboring a&nbsp;<em>KRAS&nbsp;</em>G12C mutation.

In an interview with&nbsp;Targeted Oncology, Florencia McAllister, MD, discussed the data from these analyses of the tumor microbiome in patients with pancreatic cancer and their potential significance. She also discussed the next steps necessary for validating these results.

In a recent analysis published in <em>JAMA</em>, data were evaluated from a collection of clinical trials and analyzed for important takeaways in the testing and treatment of patients with non&ndash;small cell lung cancer. The authors stress the importance of molecular testing in patients with NSCLC as more targeted therapies become available.&nbsp;<br /> &nbsp;

In an interview with&nbsp;Targeted Oncology, Muhammed Murtaza, MBBS, PhD, discussed the role for TARDIS in the treatment landscape of early-stage breast cancer, as well as the data supporting its use. He also highlighted next steps necessary for validating these results and the potential clinical value of liquid biopsies in the breast cancer space.

The United States Preventive Services Task Force is recommending that therapies like tamoxifen, raloxifene, or aromatase inhibitors be administered to women who have a high risk for developing breast cancer and low risk for the adverse events that may be caused by these therapies. This recommendation is part of an update to the USPSTF recommendation statement on treatments for reducing breast cancer risk.

The FDA has granted capmatinib a breakthrough therapy designation as a first-line treatment for patients with <em>MET </em>exon 14 skipping mutation&ndash;positive non&ndash;small cell lung cancer.

The addition of nivolumab to the standard of care temozolomide and radiation therapy was not additive in terms of progression-free survival compared with standard of care alone in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated, according to results released from the phase III CheckMate 548 trial.

Men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer who had baseline prostate-specific antigen levels &le;5.27 ng/mL demonstrated a median overall survival approaching 4 years with sipuleucel-T treatment, according to findings from the large real-world PROCEED trial.

Corey J. Langer, MD, detailed the best courses of treatment for a patient with non&ndash;small cell lung cancer to a group of physicians during a recent&nbsp;Targeted Oncology&nbsp;live case-based peer perspectives discussion.

In an interview with&nbsp;Targeted Oncology, Matthew S. Ning, MD, MPH, discussed the role for low-dose radiotherapy as treatment of patients with relapsed/refractory MCL, according to the findings from a recent analysis. He also highlighted how a multidisciplinary approach can impact the treatment of patients with MCL.

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.