#NETSPOT NOVARTIS UPDATE#
#NETSPOT NOVARTIS TRIAL#

Afinitor, marketed in some countries as Votubia®, is approved for indications related to advanced breast cancer, advanced kidney cancer, advanced pancreatic neuroendocrine tumor-and as of February 2016, for adults with progressive, well-differentiated, nonfunctional NETs of gastrointestinal (GI) or lung origin that are unresectable, locally advanced, or metastatic. Novartis’ marketed drugs for neuroendocrine tumors include Afinitor® (everolimus), which generated $1.516 billion in net sales last year, down 6% from $1.607 billion in 2015. “The isotopes don’t change the nature of the chemical entity, and they don’t change the ability for targeting.”

“This approach attaches radioisotopes to therapeutic molecules to deliver therapeutics and imaging in one injection. “Theragnostics is a very straightforward proposition for physicians dealing with nuclear medicine,” AAA CEO and founder Stefano Buono told GEN in 2015. That pipeline includes prostate cancer treatment candidates 177Lu-PSMA-R2 and its companion diagnostic 68Ga-PSMA-R2 177Lu-NeoBOMB1, a new-generation antagonist bombesin analog targeting gastrin-releasing peptide receptor (GRPR)-expressing malignancies, and its companion diagnostic, 68Ga-NeoBOMB1 and Annexin V-128, a single-photon emission computed tomography (SPECT) diagnostic candidate for assessing apoptotic and necrotic processes present in a number of oncology and cardiovascular disease conditions, as well as in autoimmune disorders.ĪAA also markets two drug kits for radiolabeling somatostatin analog peptides to help diagnose somatostatin receptor-positive NET lesions, Netspot® (formerly known as Somakit-TATE) and Somakit TOC™. “With Lutathera, we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize AAA's broader RLT pipeline and an exciting technology platform.” “Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” Bruno Strigini, CEO of Novartis Oncology, said in a statement.

#NETSPOT NOVARTIS TRIAL#

Novartis noted in its announcement yesterday that the NETTER-1 trial demonstrated a 79% reduction in the risk of disease progression, with an interim median progression-free survival rate of 8.4 months that had yet to max out. Improve the format, traceability, uniformity, and completeness relating to clinical data-including from the Phase III NETTER-1 trial, which generated positive results.

#NETSPOT NOVARTIS UPDATE#

Provide a safety update on clinical and nonclinical studies.Conduct subgroup analyses for gender, age, and racial subgroups, as well as other stratification factors and “important” disease characteristics.The first review in December 2016 ended with a Complete Response Letter directing AAA to:

In the U.S., the FDA has set a Prescription Drug User Fee Act (PDUFA) target decision date of January 26, 2018, for Lutathera. Lutathera, which is designed to treat NETs, last month won European Commission approval for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Novartis said the deal would also boost its oncology portfolio, both short-term through product launches and long-term through a new technology platform it said had potential applications across a number of oncology early development programs. Novartis said it intends to acquire Advanced Accelerator Applications (AAA) for $3.9 billion cash, in a deal designed to expand the buyer’s neuroendocrine tumor (NET) pipeline with radiopharmaceutical candidates led by the first-in-class RadioLigand Therapy (RLT) Lutathera® (177Lu-Dotatate), now under FDA re-review.

Netspot novartis