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NewsThe FDA has granted final approval to Bravnetsa (lutetium Lu 177 dotatate), the first radiopharmaceutical biosimilar deemed bioequivalent and therapeutically equivalent to Lutathera, for adults with SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The approval, based on the ERASMUS study, showed a 17% overall response rate and a median duration of response of 35 months. This marks a significant step toward expanding patient access to this targeted radiotherapy.
The FDA has officially approved Bravnetsa (lutetium Lu 177 dotatate; PNT2003), a biosimilar to Lutathera, for adult patients with somatostatin receptor (SSTR)-positive GEP-NETs — including foregut, midgut, and hindgut NETs. Approved via the abbreviated new drug application (ANDA) pathway, Bravnetsa is the only radiopharmaceutical the FDA has determined to be both bioequivalent and therapeutically equivalent to its reference product, Lutathera.
Efficacy data come from the phase 1/2 ERASMUS study, which enrolled 1,214 patients. Among the 145 RECIST-evaluable GEP-NET patients, the investigator-assessed overall response rate (ORR) was 17%, including 3 complete responses, with a median duration of response of 35 months.
By the Numbers:
Why it matters: With a second lutetium Lu 177 dotatate product (Bexlutry) also recently approved, competition in this space could improve supply reliability and broaden access for patients with this rare and difficult-to-treat cancer.
