The Targeted Pulse: The Latest FDA Actions Across Cancer Types and Exploring the Efficiency of Remote Pharmacists in Community Oncology

²²⁵Ac-SSO110, an SST2 antagonist, Granted Orphan Drug Status in SCLC

The FDA has granted ²²⁵Ac-SSO110 (satoreotide), a somatostatin receptor 2 antagonist, orphan drug designation (ODD) for the management of small cell lung cancer (SCLC). In the global, open-label phase 1/2 SANTANA-225 trial, investigators will evaluate safety, tolerability, preliminary efficacy, and recommended phase 2 dose for patients with extensive-stage SCLC or Merkel cell carcinoma. This trial is expected to begin in the first quarter of 2025. In addition, ²²⁵Ac-SSO110 will be evaluated in combination with⁶⁸Ga-SSO120 as part of a theranostic approach for targeted radionuclide therapy.

“..The FDA’s ODD will support our objective to accelerate the development of ²²⁵Ac-satoreotide through human trials to provide a potentially life-saving therapy to patients with limited alternatives,” said Manfred Rüdiger, chief executive officer at Ariceum Therapeutics, in a press release. For more information regarding ²²⁵Ac-satoreotide, access the full article here.

Unveiling Key Insights Behind the Dato-DXd Approval for HR+/HER2– Breast Cancer

For those looking to make the most of their drive into work, this podcast features Aditya Bardia, MD, MPH, FASCO, who provides deeper insights into the FDA approval of datopotamab deruxtecan (Dato-DXd) for unresectable or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer. Bardia, a professor in the department of medicine, division of hematology/oncology, director of translational research integration, at UCLA Health Jonsson Comprehensive Cancer Center in Los Angeles, California, delves into Dato-DXd’s mechanism of action and the key findings from the phase 3 TROPION-Breast01 trial (NCT05104866).

“Antibody-drug conjugates are slowly replacing chemotherapy, and we are seeing more and more antibody-drug conjugates come in for metastatic breast cancer in [the] HR+ setting but also triple negative breast cancer [TNBC]. Specifically for Dato-DXd, it is being evaluated as a first-line therapy for patients with metastatic TNBC. It is also being evaluated for localized TNBC. So, a lot of exciting trials that are ongoing that will further change the therapeutic landscape in this setting,” adds Bardia. Access this podcast, here, and look out for more Targeted Talks episodes.

FDA Bestows RMAT Designation on Gemogenovatucel-T in Ovarian Cancer

Gemogenovatucel-T (Vigil) has been granted regenerative medicine advanced therapy (RMAT) designation by the FDA for maintenance treatment. The RMAT designation applies to those with newly diagnosed, advanced stage IIIB/IV ovarian cancer who are homologous recombination proficient, have high clonal tumor mutational burden, and are in complete response following debulking surgery and frontline platinum-based chemotherapy. Data from the phase 2b VITAL trial (NCT02346747) provide evidence supporting the designation. In the trial, gemogenovatucel-T was compared with placebo, showing an overall survival benefit.

“This important recognition affirms that [gemogenovatucel-T] has the potential to extend patient survival and may offer a safer, more precise therapeutic approach to a population in urgent need of innovative solutions,” said David Shanahan, chief executive officer of Gradalis, in a press release. For more information on results, access the full article here.

FDA Moves to Include HER2-Ultralow Status in PATHWAY HER2 (4B5) Test

The FDA has expanded the approval for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to include patients with HR+, HER2-ultralow metastatic breast cancer who may benefit from fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu). T-DXd’s approval was expanded in January 2025 to included unresectable or metastatic HR+, HER2-low, or HER2-ultralow breast cancer that has progressed on at least 1 endocrine therapy. This expansion for the PATHWAY HER2 (4B5) Test aligns with T-DXd’s expanded approval.

“The approval of our test for determining HER2-ultralow status offers new hope to patients by providing a possible path to HER2-targeted treatment where none existed before, helping clinicians transform outcomes for many facing this challenging disease,” Matt Sause, chief executive officer of Roche Diagnostics, said in a press release. More information and supporting data, access the full article here.

Remote Clinical Pharmacists: An Efficient Strategy Boosting Practices

Remote-based clinical pharmacists are increasingly being integrated into community practices as a cost-effective solution. The US Oncology Network sought to evaluate the clinical and financial impact of this integration. Andrea Roman, PharmD, BCOP, from the US Oncology Network and McKesson, discussed the research surrounding this shift, highlighting its numerous advantages. These include improvements in provider burnout, enhanced patient care, and more.

“We are helping those on the front end and hoping to prevent hospital admissions, dose reductions, or coming off therapy sooner than maybe patients would if they are starting at the right dose from the start. Also, [we are focused on reducing the cost of care]. A lot of times the cost of cancer [impacts patients significantly]. I think we will be able, hopefully in the future, to show those numbers and reduce the overall cost of care,” Roman told Targeted Oncology^TM in an interview. Access the full interview here.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.

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