Take a look at some of the important updates from CancerNetwork last week you might have missed in the world of oncology from the FDA and the journal ONCOLOGY.
Each Monday, CancerNetwork® highlights the most important content from the previous week in oncology news.
Recently, Athenex met with the FDA regarding its combination of oral paclitaxel plus encequidar to treat patients with metastatic breast cancer. Additionally, the latest issue of the journal ONCOLOGY® featured a patient case with prostate cancer, as well as a short examination of COVID-19’s origins.
Athenex Discusses Deficiencies of Oral Paclitaxel Plus Encequidar for Metastatic Breast Cancer in FDA Type A Meeting
The additional data and analyses on patient subgroups helped Athenex to spotlight a more detailed perspective of the risks and benefits associated with the combination of oral paclitaxel and encequidar in patients with metastatic breast cancer. The drug company also suggested collecting more overall survival data to better inform the design of a new clinical trial.
The FDA recommended that Athenex implement a “well-designed and well-conducted” clinical trial to address these deficiencies, with the complete response letter specifically suggesting risk mitigation strategies, such as dose optimization or exclusion criteria, to improve toxicities for patients. Athenex expects to announce plans for an updated clinical trial that will be presented to the FDA towards the end of 2021.
Shaji Kumar, MD, Details Toxicities With Daratumumab Plus Lenalidomide/Dexamethasone in Frontline MM
CancerNetwork® sat down with Shaji Kumar, MD, of the Mayo Clinic, at the 2021 European Hematology Association Congress to discuss long-term toxicities associated with daratumumab (Darzalex) plus lenalidomide (Revlimid) and dexamethasone in newly diagnosed multiple myeloma. Kumar mentioned that there were no new safety signals detected at the 5-year follow-up of the phase 3 MAIA trial (NCT02252172).
Median Lobe Urethral Embolus After Focal Ablation of Gleason 7 Prostate Cancer
This is the case of a man, aged 56 years, who presented with urinary intermittency, frequency, urgency, and dysuria 5 months after undergoing focal laser ablation (FLA) of Gleason 3+4=7 prostate cancer (PC).
To the investigators’ knowledge, this is the first case of intermittent urethral obstruction by a sloughed median prostatic lobe following FLA. FLA is an emerging therapy for low- or intermediate-grade PCs. The case highlights the need for continued evaluation of long-term outcomes of this procedure.
Questions Linger Around COVID-19’s Origin
We may never know where this virus came from. What we do know for certain is that the incredible strength and collaboration of the scientific community have allowed us to regain some semblance of normalcy. The development and rollout of multiple effective vaccine options have been the medical miracle of our lifetime.
Tanios S. Bekaii-Saab, MD, Discusses Key Findings From a Genomic and Immune Profiling Study in Intrahepatic Cholangiocarcinoma
At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, CancerNetwork® spoke with Tanios S. Bekaii-Saab, MD, of Mayo Clinic, about key findings from a genomic and immune profiling study in patients with intrahepatic cholangiocarcinoma. Specifically, he examines the incidence of IDH1/2 mutations and key findings related to these genetic abnormalities.
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