An advisory panel to the Food and Drug Administration unanimously backed approval of Novartis' CAR-T therapy tisagenlecleucel for an aggressive type of leukemia, likely signaling a clear path towards a regulatory OK later this year. Novartis is seeking approval to use the therapy on patients ages three to 25, particularly in patients who have failed to respond to standard treatments - something that occurs in over 600 people in the United States yearly. Novartis' therapy is the first CAR-T treatment to be reviewed by the FDA and, as such, is seen as a marker for the types of concerns the agency might have with other candidates such as Kite Pharma's axi-cel. Novartis is developing CTL019 for use in lymphoma, and its pipeline includes other CAR-T therapies targeting an array of blood cancers.
A group of cancer experts advising the FDA has asked the agency to approve a Novartis AG (ADR) (NYSE:NVS) leukemia drug now going by the name CTL019.
This therapy is a one-time treatment for children and young adults affected by the most common form of childhood cancer, acute lymphoblastic leukemia or ALL. "This is an entirely new way of treating cancer and I think these cellular therapies are only in their first chapter". This technology involves the removal of immune cells from the patient's blood and then reprogramming them to recognize and attack malignant cells and injecting them back into the patient.
Aru takes Tour lead (4)
Froome's teammates rode at the front with Aru's squad just behind, but showed no interest in reducing the gap with the breakaways. Aru collected bonus seconds for his placing and now leads Froome by six seconds in the general classification.
A revolutionary new cancer therapy developed by Swiss pharmaceutical major Novartis moved closer to the market on Wednesday after getting unanimous approval from a panel of USexperts. After the cells are removed by medical personnel, they are frozen, shipped to Novartis (the therapy's maker), processed, refrozen, and shipped back to the medical center.
There are still plenty of challenges ahead for Novartis and other companies in the CAR-T space.
Tisagenlecleucel's benefit for ALL patients who have relapsed from other treatments was clear before the meeting. Initially, Novartis plans to make the treatment available at 30 to 35 cancer centers that have been trained and certified in administering the immunotherapy and providing follow-up care.
Novartis is now poised to be the first. Patient advocacy groups praised the FDA's findings and the impact the new treatment could have on patients with ALL.
NASA probe successfully peers into Jupiter's Great Red Spot
Juno chalked another one up for the history books, as it completed the first close flyby of Jupiter's Great Red Spot . Today, NASA released the first photos from the Juno satellite's close encounter with the solar system's largest storm.
Observers crowded into the FDA's presentation room this morning, rubbing shoulders with CAR-T celebs like Penn's Carl June with many, many more looking on online.
In addition to understanding that process, the staffers wrote, Novartis will need to understand critical product quality attributes unique to autologous auto T-cell products-as well as to understand and address sources of variability seen in the products.
Last year, when Kite hired Christine Cassiano its new SVP of corporate communications and investor relations, she said that communication around CAR-T therapies is "about making it relatable to patients".
Treatments involving live cells, known as "biologics" are generally far more hard to manufacture than standard drugs, and the panelists also expressed concerns about whether Novartis would be able to produce consistent treatments and maintain quality control as it scaled up its operation.
Liu Xiaobo suffers respiratory failure
The Nobel laureate and his family, who are being closely guarded in the hospital, could not immediately be reached for comment. The Western doctors said the evacuation would need to take place soon before Mr Liu's condition deteriorates further.