Novartis Is First To Finish Line With CAR-T Cancer Drug Nod

Novartis won FDA approval for its CAR-T drug Kymriah on Wednesday

Also on Wednesday, the FDA broadened the approval of Genentech Inc.'s Actemra (tocilizumab) to treat vehicle (chimeric antigen receptor) T-cell-induced severe or life-threatening cytokine release syndrome in patients 2 years old and up. According to Children's of Alabama, more than 190 children in Alabama are diagnosed with various forms of cancer each year, including ALL.

"We've never seen anything like this before and I believe this therapy may become the new standard of care for this patient population", Dr Stephan Grupp of Children's Hospital of Philadelphia said in a statement.

The treatment will be sold under the name Kymriah, and is approved for children and young adults up to age 25 with cancers that don't respond to traditional treatment, or who are suffering from a second relapse, a broad indication that will give more patients access to the novel technology.

Novartis' CAR-T, which will be marketed as Kymriah, leads an emerging field of cell therapies created to engineer the body's immune cells to seek out and destroy cancers. Kymriah is intended for people with B-cell ALL whose cancer hasn't responded to or has returned after treatment, the FDA said. They are then reintroduced back into the patient to do battle against the tumor.

Lorde Perplexes Audience By Doing Everything But Singing At 2017 MTV Awards
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While promising, CAR-T treatments won't be like other drugs that win FDA approval, which can quickly wind up on pharmacy shelves and hospitals. Tisagenlecleucel carries a boxed warning for cytokine release syndrome (CRS) and neurological events, which can be life threatening.

However, this type of therapy is not without risk of severe side effects as the immune system goes into high gear. Other possible severe side effects could include serious infection, low blood pressure, kidney injury, fever and decreased oxygen.

Novartis plans additional filings for Kymriah in the US and EU later this year, including applications with the FDA and European Medicines Agency, for the treatment of adult patients with r/r diffuse large B-cell lymphoma (DLBCL).

The drug Kymriah was developed by Novartis Pharmaceuticals and the University of Pennsylvania. Researchers hope that this will lead to further CAR-T treatments that can fight more complicated cancers such as pancreatic, breast, and brain cancer. Clinical trials using CAR-T cells showed 69% of patients had complete resolution of CRS within 2 weeks following 1 or 2 doses of tocilizumab, according to the release.

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