Curium™ announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for BEXLUTRY™ lutetium Lu 177 dotatate injection for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
asserted
Administration → announce → adults
BEXLUTRY™ is a radioligand therapy designed to deliver targeted radiation to GEP-NETs by binding to somatostatin receptors commonly expressed on these tumors.
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BEXLUTRY → design → tumors
NETs originate from neuroendocrine cells, which are specialized cells widely dispersed throughout the body’s organs.
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which → originate → organs
The site of origin can vary because of the broad distribution of neuroendocrine cells.
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site → vary → cells
GEP-NETs represent 60-70% of NETs.
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NETs → represent → NETs
BEXLUTRY™ is a radioligand equivalent approved through the FDA’s 505(b)(2) pathway targeting LUTATHERA® (lutetium Lu 177 dotatate), supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to a previously approved radiopharmaceutical therapy.
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that → approve → therapy
Renaud Dehareng, Curium’s Group Chief Executive Offer, said: “FDA approval of BEXLUTRY™ is a defining milestone for Curium™ as we expand our offering into oncology therapeutics.
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we → say → therapeutics
With over 100 years of experience in nuclear medicine and a long-standing commitment to the NET community, we are now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly.
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we → stand → theranostics
For decades, Curium™ has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery.
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Curium → earn → reliability
We are applying that same discipline and commitment to help eligible NET patients access radioligand therapy with confidence.”
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patients → apply → confidence
Mike Patterson, Curium’s North American Chief Executive Officer, said: “As the only vertically integrated, lutetium-based NETs therapy manufacturer, Curium™ is uniquely positioned to support a reliable supply of BEXLUTRY™ and help sites of care prepare for radioligand therapy delivery at scale.
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sites → say → scale
Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer.
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approval → bring → cancer
Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy.
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priority → support → therapy
About BEXLUTRY™
INDICATIONS AND USAGE
Bexlutry™ (lutetium Lu 177 dotatate injection) is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
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INDICATIONS → indicate → tumors
Bexlutry contributes to a patient’s overall long-term cumulative radiation exposure.
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Bexlutry → contribute → exposure
Long-term cumulative radiation exposure is associated with an increased risk for cancer.
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exposure → associate → cancer
These risks of radiation associated with the use of Bexlutry are greater in pediatric patients than in adults.
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risks → associate → adults
Radiation can be detected in the urine for up to 30 days following Bexlutry administration.
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Radiation → detect → administration
In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to patients receiving high-dose long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0) versus (54%/1%); thrombocytopenia (53%/1%) versus (17%/0); and neutropenia (26%/3%) versus (11%/0).
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myelosuppression → occur → 11%/0
In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose.
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nadir → occur → dose
Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels.
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% → develop → levels
Fifteen of the nineteen patients in whom platelet recovery was not documented had post-nadir platelet counts.
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recovery → document → counts
Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3.
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5 → improve → Grade
In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (MDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to no patients receiving high-dose long-acting octreotide.
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syndrome → follow → octreotide
In ERASMUS, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia.
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4 → develop → leukemia
In ERASMUS, 8 patients (< 1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection.
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patients → develop → injection
Two of these patients had underlying renal impairment or risk factors for renal failure (e.g., diabetes or hypertension) and required dialysis.
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Two → have → dialysis
Patients with baseline renal impairment may be at increased risk of toxicity due to increased radiation exposure.
uncertain
Patients → increase → exposure
Bexlutry contributes to a patient’s overall long-term cumulative radiation exposure.
asserted
Bexlutry → contribute → exposure
Long-term cumulative radiation exposure is associated with an increased risk for cancer.
asserted
exposure → associate → cancer
These risks of radiation associated with the use of Bexlutry are greater in pediatric patients than in adults.
asserted
risks → associate → adults
Radiation can be detected in the urine for up to 30 days following Bexlutry administration.
asserted
Radiation → detect → administration
In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to patients receiving high-dose long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0) versus (54%/1%); thrombocytopenia (53%/1%) versus (17%/0); and neutropenia (26%/3%) versus (11%/0).
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myelosuppression → occur → 11%/0
In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose.
asserted
nadir → occur → dose
Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels.
asserted
% → develop → levels
Fifteen of the nineteen patients in whom platelet recovery was not documented had post-nadir platelet counts.
asserted
recovery → document → counts
Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3.
asserted
5 → improve → Grade
In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (MDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to no patients receiving high-dose long-acting octreotide.
asserted
syndrome → follow → octreotide
In ERASMUS, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia.
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4 → develop → leukemia
In ERASMUS, 8 patients (< 1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection.
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patients → develop → injection
…and 59 more, not listed.
The Aporia
