This year has been another year full of oncology approvals, proving that the oncology pipeline is robust with first-of-the kind molecules, competitor products for existing agents, and biosimilars, according to Jeremy Whalen, PharmD, BCOP, specialty clinical program director, oncology, Prime Therapeutics.
“As more is being discovered and understood within the tumor microenvironment and specific cancer genomics, it is being paired with the emerging precision oncology practice,” Whalen says. “Manufacturers are investing in these pathways and targets looking for the next paradigm shifting therapy.”
Prime is actively monitoring 15 products that could receive approval before the end of the 2018. “These would join the additional 13 new products that already received approval this year and the more than 20 products that had expanded approvals,” Whalen says.
Jonathan R. Ptachcinski, PharmD, BCPS, BCOP, clinical pharmacist practitioner, University of North Carolina Medical Center, says the oncology pipeline is continuing to be robust with possible upcoming approvals in a variety of both solid hematologic malignancies. “Approvals are anticipated for multiple new agents as well as a number of biosimilar specialty medications which are likely to be approved at the end of 2018 and early 2019,” Ptachcinski says.
One novel mechanism is the one targeted by larotrectinib, (LOXO-101), a pan-TRK inhibitor under FDA priority review for adult and pediatric patients with locally advanced or metastatic solid tumors that harbor a NTRK gene fusion, he says. “Reports from phase 2 data suggest that the benefit is seen across multiple solid tumor types which may help justify acquisition costs,” Ptachcinski says.
The outlook for healthcare executives will continue to focus on balancing the cost of administration of new agents, according to Ptachcinski. “Specifically, I anticipate that they will want to ensure that these new agents possess an improvement in outcomes that is commensurate with the increased cost versus. a small—yet statistically significant—benefit. Also, executives may wish to evaluate whether reimbursement for the cost of new therapies at will least cover drug administration cost or potentially also allow for new bottom-line margin.”
Erin Bastick, PharmD, RPh, is a staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.