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"This designation is a significant validation of not only our onvansertib clinical program, which is now eligible for priority review and accelerated approval, but it also signifies recognition of the medical need for new effective treatment options.”

"Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency’s questions as they arise. We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer."

In an interview with Targeted Oncology, Maria E. Cabanillas, MD, discussed the findings from a clinical trial evaluating potential atezolizumab combinations in patients with anaplastic thyroid cancer.

"The ability for NGS to assess response across a continuum of relevant MRD threshold levels is an important consideration for applying MRD testing in clinical practice."

“Although these are early data, we are encouraged by these findings. The depth of response is particularly impressive in some patients."

"Pegfilgrastim plays a vital role in oncology care, and this acceptance by FDA is an important step toward giving oncologists and their patients greater access by providing another option to help support the immune system following chemotherapy."

Nivolumab plus ipilimumab in combination with chemotherapy was granted approval for the frontline treatment of patients with metastatic or recurrent non–small cell lung cancer who do not harbor EGFR or ALK genomic tumor abberations.

In an interview with Targeted Oncology following the announcement of sacituzumab govitecan accelerated FDA approval, Hope Rugo, MD, discussed the published data from the phase 1/2 basket trial and the relevance of having sacituzumab govitecan available for the treatment of patients with metastatic triple negative breast cancer.

"Our trial, together with ongoing randomized trials, provides more evidence on the risks and benefits of immunotherapy as a neoadjuvant treatment, and could help to answer questions regarding the optimal duration, best surrogate endpoint, and best predictive biomarkers for treatment."

The immune checkpoint inhibitor induced 1 objective response but appeared safe as treatment of patients with metastatic high-grade neuroendocrine neoplasms in 2 open-label phase 2 clinical trials.

Targeted Oncology reviews trending news online for the week of May 22, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

The FDA has granted approval to brigatinib for the frontline treatment of patients with ALK-positive metastatic non–small cell lung cancer, as detected by an FDA-approved test.

Fam-trastuzumab deruxtecan-nxki has received an Orphan Drug designation for the treatment of patients with gastric or gastroesophageal junction cancer.

In an interview with Targeted Oncology, Lajos Pusztai, MD, DPhil, discussed the findings from the phase I/II clinical trial of durvalumab in combination with concurrent nab-paclitaxel and doxorubicin plus cyclophosphamide in the neoadjuvant setting for patients with triple-negative breast cancer.

"Durvalumab plus standard chemotherapy delivered a promising median overall survival rate for patients with previously untreated, inoperable malignant pleural mesothelioma."

In an interview with Targeted Oncology, following a tweet chat on prostate cancer, Tian Zhang, MD, discussed the key takeaways from the tweet chat discussion and highlighted both the role of molecular testing and the impact of the recent FDA approvals in prostate cancer.

In an interview with Targeted Oncology, Robert L. Coleman, MD, FACOG, FACS, discussed the importance of molecular testing in ovarian cancer and how the treatment landscape will continue to evolve in tailoring treatment to patients based on the biology of their tumors, which was the topic of his lecture at the 2020 Society for Gynecologic Oncology (SGO) Annual Meeting.

Two companion diagnostic assays were granted FDA approval to identify male patients with metastatic castration-resistant prostate cancer who are eligible for treatment with olaparib.

“In this study, we evaluated ruxolitinib as a bridge, relapse, and GVHD prevention agent in patients with myelofibrosis. The regimen was well tolerated, with an acceptable rate of organ toxicity."

A new analysis of nearly 600 patients with myelofibrosis found patients who take ruxolitinib progress to blast phase at approximately the same rates as those who are ruxolitinib-naïve.

Vivek Subbiah, MD, discusses the potential to combine tivozanib with other agents, particularly ipilimumab, as treatment of patients with renal cell carcinoma.

In an interview with Targeted Oncology, Rashmi Murthy, MD, discussed the final results from the HER2CLIMB study and the future of tucatinib as it makes its way to the community setting as treatment of advanced HER2--positive breast cancer.

Based on data from a matching-adjusted indirect comparison study, cabozantinib the safety and efficacy of cabozantinib may be comparative to regorafenib in advanced hepatocellular carcinoma.

“This randomized phase III study for the first time provides prospective long-term results on survival and other end points of interest after standard treatment with CHOP in patients with PTCL beyond 60 years who represent the majority of [patients with] PTCL, generally less eligible for more intense therapies like autologous and allogeneic transplantation."

Momelotinib for the treatment of patients with myelofibrosis may address concerns with the development of cytopenias, an issue no approved therapy has been able to solve.

"Promising results would pave the way to a larger clinical trial that would include non-cancer patients at high risk for COVID-19 complications.”

“Although PARP inhibitor treatment has demonstrated radiographic and PSA responses in patients with BRCA alterations (4–8), the data presented here offer compelling evidence that response to PARP inhibitors is limited in men with mCRPC harboring an ATM, CDK1/2, or CHEK2 alteration."

Atezolizumab has received its fifth indication in NSCLC as treatment of adult patients with metastatic non–small cell lung cancer who have high PD-L1 expression.

A study found correlation between body mass index in patients with non–small cell lung cancer treated with atezolizumab and improved survival outcomes.

Long-term data from a phase Ib/II trial of the BTK inhibitor acalabrutinib were recently published. Acalabrutinib appears to evoke durable responses with good safety and efficacy.