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The November 2017 issue of Pharmafocus is now live!

The November edition of Pharmafocus is now live and available to read online here!

Gilead gets FDA nod for revolutionary blood cancer treatment

Only weeks after Gilead announced the completion of Kite, it got the news it was hoping for with the FDA's approval for the CAR-T therapy, Yescarta, to become only the second treatment on the market.

The therapy still has a way to go to recoup the $12 billion Gilead agreed to takeover Kite, however, with a price $373,000 per treatment and an ability to expand the indication, it’s looking like a sound deal – investors seem to agree, with shares up 4%.

CAR-T treatment is given ‘historic’ first approval by FDA

Novartis has received approval for its CAR-T treatment of paediatric and young adults with a form of acute lymphoblastic leukaemia (ALL). The approval marks a breakthrough for this type of treatment that reengineers the body’s own immune system to combat cancer and had the FDA referencing its decision as ‘historic’.

It was an approval that was widely expected, after an FDA advisory committee gave the drug the thumbs up but the decision has been arrived at sooner than expected. It means hundreds of patients could be eligible for the treatment immediately.

Novartis’ breakthrough cancer treatment receives FDA advisory approval

In what could well be a game-changing decision for cancer treatment, the FDA advisory panel gave Novartis’ CAR-T Therapy, CTL019 (tisagenlecleucel), unanimous approval in a 10-0 vote in favour of the treatment.

Novartis revealed Phase 2 data from a small study of patients that displayed ground-breaking efficacy in treating patients with acute lymphoblastic leukaemia, with 83% of patients in complete remission three months after treatment.

World Immunotherapy Congress 2017

Up to 120 jobs set to go as Novartis closes down Cell and Gene Therapies unit

News has emerged that Novartis plans to close down its Cell and Gene Therapies unit, with up to 120 workers set to lose their jobs.

Although Novartis has consistently emphasised its focus on CAR-T therapies, which reengineers T-cells to attack cancer cells, the closure of this unit raises serious doubts over this particular field of cancer therapy.

Researchers launch CAR-T cell therapy trial in head and neck cancer

A health human CAR-T cell (Credit: Celgene)

A pioneering trial is beginning in London, where doctors are harnessing patients’ own immune systems to find a new effective treatment for resistant head and neck cancer.

The trial is the first to use immunotherapy techniques, which have been successfully used to develop new treatments for several cancers, including melanoma and lung cancer, in head and neck cancers.

Kite Pharma says trial death was unrelated to KTE-C19

Kite has confirmed last week’s rumours that a patient had died during its Phase I/II trial for the KTE-C19 non-Hodgkin's lymphoma treatment, while reassuring investors that the death was unrelated to the treatment.

Kite shares fell by more than 16% on Friday when the rumours circulated and a delay in the trial was considered a possibility, but have recovered since Kite CEO Arie Belldegrum reported the update to analysts.

"It is not now, nor has it ever been, on any type of clinical hold by the FDA or any other regulatory body," Belldegrun said this week.  

Celgene enters 10-year $1 billion pact with Juno

Celgene just recently bought Quanticel Pharmaceuticals to aid cancer drug discovery

Celgene has invested $1 billion into Juno Therapeutics as part of a 10-year partnership aiming to study cures for cancer and autoimmune diseases.

The two companies will leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on Chimeric Antigen Receptor Technology (CAR-T) and T Cell Receptor (TCR) technologies.

Car-T therapy involves removing a cancer patient’s white blood cells, re-engineering them in a lab to encourage them to destroy tumours – and then reintroducing them back into the patient.

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