A potential competitor to existing drugs used to treat low blood counts and infections due to chemotherapy will have its day at the Food and Drug Administration. However, the data used to seek approval got mixed opinions from oncologists.
Henderson, Nevada-based Spectrum Pharmaceuticals said Thursday that the FDA would review its application for Rolontis (eflapegrastim), a granulocyte colony-stimulating factor (G-CSF) therapy for treating chemotherapy-induced neutropenia. The news coincided with an announcement by the company that the first cohort of its clinical trial of a drug for certain patients with non-small cell lung cancer had failed. Spectrum said FDA will decide on whether or not to approve Rolontis by Oct. 24, 2020.
In a note to investors, B. Riley FBR analyst Mayank Mamtani wrote that the drug would see a likely approval and launch around the fourth quarter of next year, with an entry into the G-CSF market – valued at $3 billion or more – in 2021.
The application for Rolontis is based on data from two Phase III clinical trials, ADVANCE and RECOVER, which enrolled a total of 643 early-stage breast cancer patients undergoing chemotherapy. Rolontis demonstrated non-inferiority to Amgen’s Neulasta (pegfilgrastim).
According to the Phase III data, presented at the American Society of Clinical Oncology in June, Rolontis was non-inferior to Neulasta, meaning it showed equivalent efficacy, along with a comparable safety profile. In addition, an integrated analysis of the data from the two studies showed an absolute risk reduction of severe neutropenia by 6.5% compared with Neulasta in the first cycle of therapy, meaning that the percentages of patients in the Rolontis and Neulasta arms who experienced severe neutropenia were 17.5% and 24%, respectively.
“The primary endpoint of non-inferiority in duration of severe neutropenia was attained alongside a comparable safety profile with potential differentiation arising from absolute reduced risk of severe neutropenia incidence,” Mamtani wrote, adding that commercial launch would likely occur in late 2020 or early 2021.
The FDA approved Novartis generics division Sandoz’s biosimilar version of Neulasta, Ziextenzo (pegfilgrastim-bmez), last month. The Center for Biosimilars reported Nov. 15 that it had been launched in the U.S., with its list price of $3,925 representing a 37% discount from that of the reference product. Coherus makes another Neulasta biosimilar, Udenyca (pegfilgrastim-cbqv).
Still, Spectrum’s product got a somewhat mixed reception from oncologists on whether it could overtake Neulasta or its biosimilars.
“This is not of huge scientific interest as effective treatments are available,” wrote Dr. Peter Schmid, group leader at the Barts Cancer Institute in London, in an email, referring to the data from ASCO.
Others were more positive. “I think making these drugs more widely available can only be a good thing, provided proper trials have been done, as seems to be the case here,” wrote Dr. Justin Stebbing, professor of cancer medicine and medical oncology at Imperial College, also in London.
Another oncologist, Dr. Jacopo Giuliani, at University Hospital in Ferrara, Italy, called the data “very interesting” and wrote that the drug could have an effect on febrile neutropenia, given Rolontis’ non-inferiority on that measure. “Probably, eflapegrastim may find its niche in patients with previous risk factors” such as pre-existing neutropenia, he wrote.
Photo: FDA (via Flickr – free of copyright protection)
