"This approval provides another treatment choice for patients with these rare cancers."Īs well as adding Lutathera and 177Lu-PSMA-R2 (in Phase 1/2 study in prostate cancer) to Novartis' oncology portfolio, the acquisition of Advanced Accelerator Applications also brings on board a portfolio of diagnostics. "GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," commented Richard Pazdur, director of the FDA's Oncology Center of Excellence, in a Jan. They include Tarveda Therapeutics Inc.'s PEN-221, which targets the somatostatin receptor and carries a potent cytotoxic, and is expected to move into Phase 2a in first quarter of 2018 and OctreoPharm Sciences GmbH's 177Lu-OPS201 PRRT, which has been assessed under compassionate use in a pilot study.
There are a few other companies developing therapeutics for NETs. Roughly one in 27,000 people are diagnosed with GEP-NETs each year, and patients with neuroendocrine tumors with distant metastases have a five-year survival probability of around 35%. Approval: 2016 RECENT MAJOR CHANGES Dosage and Administration ( 2) 9/2018 INDICATIONS AND USAGE NETSPOT, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron. "For 30 years, Novartis has supported the NET community with the development of therapeutics in NET and carcinoid syndrome," said Susanne Schaffert, chair and president, Advanced Accelerator Applications, in a statement. NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection), for intravenous use Initial U.S. Objective response rate, composed of complete and partial responses, was 13% for the Lutathera arm compared to 4% in the Octreotide LAR arm. In the NETTER-1 study, median progression-free survival had not been reached in the Lutathera arm, versus 8.5 months for the 60 mg octreotide LAR arm. Novartis acquired Advanced Accelerator for $3.9 billion last October, closing the deal last week - just in time for the FDA's target decision date for the nuclear medicine company's lead radioligand therapy, Lutathera (lutetium Lu 177 dotatate).
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