Kite Pharma wasn’t expecting a regulatory decision for its non-Hodgkin lymphoma treatment until November, but this week, the company got the FDA’s O.K.
The approval of axicabtagene ciloleucel (Yescarta) marks the second time in the two months that the FDA has given the nod to a CAR-T therapy, a treatment made from a patient’s own engineered cells. The first, tisagenlecleucel from Novartis (NYSE: NVS), was approved in August to treat a severe form of pediatric leukemia.
Gilead Sciences (NASDAQ: GILD), the Foster City, CA, company that acquired Kite, put a $373,000 price tag on the Kite therapy, a discount to the $475,000 price of Novartis’ treatment. But Novartis offered performance pricing: patients who don’t respond to the treatment within a month don’t have to pay. Gilead’s announcement offered no such pricing option, but alternative pricing isn’t completely off the table. The company later told Xconomy that it is talking with payers who have varying degrees of interest different pricing models.
In other news this week, two senators proposed a short-term Obamacare fix, Vir Biotechnology revealed a global strategy to tackle infectious disease, and Eli Lilly reached a deal to get into mRNA drug development. Let’s roundup the week’s biotech and health policy news.
IN THE CAPITAL
—Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA) released their short-term fix to shore up Obamacare markets, which were sent into deeper crisis last week by President Trump’s executive orders to cut off federal insurance subsidies and TK . The White House officially came out against the bill, while 24 senators, split between the two parties, co-sponsored it.
—The same two senators presided over a hearing about high prescription drug prices. Alexander questioned the need for complicated rebates, which are negotiated between drug companies, insurers, and middlemen in secret. Other senators also touted the need for more transparency. The witness representing the drug industry took much of the heat.
—Politico reported that Alex Azar is the leading candidate to replace recently ousted Tom Price at the head of the Department of Health and Human Services. Azar worked at HHS under George W. Bush, then was a top executive at Eli Lilly.
LEGAL & ETHICAL QUESTIONS
—A federal judge struck down patents for blockbuster eye disease medicine Restasis, which owner Allergan (NYSE: AGN) has tried to protect from generic competition. The drug giant said in September it had transferred ownership to a sovereign Native American tribe and licensed back exclusive rights. The Texas-based judge said the patents never should have been granted. He also criticized Allergan’s strategy.
—The long-awaited lawsuit that Incyte (NASDAQ: INCY) has been threatening against former employees is moving forward, the Delaware News Journal reported. Incyte alleges its cancer immunotherapy secrets were used to build a competitor, Flexus Biosciences, which Bristol-Myers Squibb (NYSE: BMY) quickly bought for as much as $1.25 billion. Industry observer Derek Lowe opines that the parties will reach a settlement before the October 2018 trial start date.
—Buzzfeed reported on Bay Area biohacker Josiah Zayner, who publicly injected himself with a CRISPR-Cas9 gene editing solution to see what happens if he knocks out the protein that keeps muscle growth in check.
DATA GOOD, DATA BAD
—Johnson & Johnson (NYSE: JNJ) dropped two antibody drugs, sirukumab for rheumatoid arthritis and talacotuzumab for acute myeloid leukemia. Up for approval, sirukumab ran into questions about patient deaths. J&J did not say why it has ended a Phase 3 study for talacotuzumab.
—After hitting rock-bottom in late 2014, Exelixis (NASDAQ: EXEL) continued a run of success with positive Phase 3 results of its flagship drug cabozantinib in liver cancer. It plans to ask … Next Page »