FDA Approves Drug for Rare Cancer That Killed Steve Jobs

Novartis AG (NVS) announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application or NDA for Lutathera for treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.

LUTATHERA, a targeted therapy that carries a radioactive component, is the first drug of its kind approved in the U.S. Following infusion, the targeting molecule binds to a specific receptor on tumor cells that is then internalized into target cells.

The drug was evaluated in two clinical studies involving more than 1,400 patients. The FDA has provided its stamp of approval for their drug Lutathera, which uses radioisotopes to target neuroendocrine tumors. The Lu-dotatate and the control groups had response rates of 18% and 3%, respectively (P .001). Patients in the Lu-dotatate arm also had a lower risk of tumor growth and mortality compared with patients who received octreotide LAR only. Of the 360 patients with GEP-NETs, 16% demonstrated a complete or partial shrinkage of their tumor.

Regarding safety, the frequency of lymphopenia, increased gamma-glutamyl transferase, vomiting, nausea, elevated AST/ALT, hyperglycemia, and hypokalemia were higher in the Lutathera arm vs the octreotide LAR arm. More serious adverse reactions could include myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, and infertility, the FDA said.

Like this



12 Апреля 2018
New Jersey Looking Towards Sports Betting
New Jersey has demonstrated recently that financial returns from legalising gambling, in particular online gambling can be huge . As of April 2018 New Jersey have spent a massive $7.2M dollars in the fight to legalise sports betting within the state borders.

15 Марта 2018
Server Requirements for Mass Mailing
The first means that the error occurred on the receiving side: maybe the client's account was blocked, or something else happened. Running your own email server may sound like a science fiction, and it may seem that it’s impossible to handle such thing.

27 Января 2018
WW Grainger (GWW) Receives Underperform Rating from Credit Suisse Group
It is positive, as 62 investors sold GWW shares while 157 reduced holdings. 62 funds opened positions while 153 raised stakes. Bsw Wealth Partners bought 1,914 shares as the company's stock declined 31.42% while stock markets rallied. 3 were sells.

27 Января 2018
Zacks Investment Research Lowers Enbridge Energy Partners (NYSE:EEP) to Sell
The firm earned "Neutral" rating on Tuesday, November 7 by JP Morgan. ( NYSE:GS ), 13 have Buy rating , 1 Sell and 16 Hold. Tortoise Capital Advisors Llc decreased Olin Corp (NYSE:OLN) stake by 19,121 shares to 42 valued at $1,000 in 2017Q3.

27 Января 2018
Nomura Reaffirms "Neutral" Rating for Urban Outfitters (NASDAQ:URBN)
It turned negative, as 37 investors sold URBN shares while 88 reduced holdings. 29 funds opened positions while 85 raised stakes. The stock increased 1.11% or $0.31 during the last trading session, reaching $28.36. (NASDAQ: URBN ) for 4.25M shares.

27 Января 2018
Olé! Sales Of Nintendo Switch In Spain Have Now Surpassed Xbox One
Well the Nintendo Switch has surpassed that milestone already even though Nintendo's console only came out back in March 2017. On the 2017 Christmas Eve, this "Sorpasso" happened; as most of the people had predicted it that this could happen.

27 Января 2018
Call of Duty: WWII's The Resistance DLC has a new trailer
Then there's new War Mode mission, Intercept, in which you're tasked with freeing fellow resistance fighters. Set days after the disaster of Mittelburg, our heroes receive intel of Doktor Straub's island location.

27 Января 2018
Japan unveils two mythical, lion-like mascots for 2019 Rugby World Cup
Rob Abernethy, the general manager of the Rugby World Cup, said the winning entry was whittled down from about 50. The shishiare sacred lion-like mythical creatures that are said to bring happiness and ward off evil.

27 Января 2018
'Game of Thrones' will return in April 2019, says star Maisie Williams
G.o.T picked up a whopping 29 percent of the vote, with deep-sea doc Blue Planet II coming a distant second with 15 percent. The things that have been driving her through her story have been very bitter and twisted and aggressive.

27 Января 2018
Halcon Resources (HK) Downgraded to "Sell" at Zacks Investment Research
Movements above 70 are interpreted as indicating overbought conditions; conversely moves underneath 30 notify oversold conditions. Currently Halcon Resources (NYSE:HK)'s shares owned by insiders are 0.9%, whereas shares owned by institutional owners are 92.7%.