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FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
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FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
Jan 7, 2025 12:13 PM

By Sneha S K and Sriparna Roy

Dec 27 (Reuters) - The U.S. Food and Drug Administration

said on Friday that it has approved an injectable version of

Bristol Myers Squibb's ( BMY ) blockbuster cancer drug, Opdivo.

Opdivo is part of a class of drugs called PD-1 inhibitors,

which enhance the immune system's ability to fight cancer by

removing its natural brakes.

Like other PD-1 drugs such as Merck's ( MRK ) Keytruda, it

was previously available through infusions and patients received

it via an intravenous drip in a health office.

The new injectable form is expected to be more convenient

for patients and could help shield the company from erosion of

sales when the patent for the intravenous version expires later

this decade.

The injection, branded as Opdivo Qvantig, has been

approved to treat most previously approved adult, solid tumor

indications, either on its own, as maintenance therapy or in

combination with chemotherapy.

The drug will be available in early January, and will be

priced at parity with the list price of the IV version, Adam

Lenkowsky, Bristol's chief commercialization officer, told

Reuters ahead of the approval.

The IV version of the drug has a list price of $7,635 per

infusion for two weeks for the lower dose and $15,269 per

infusion for four weeks for the higher 480-milligram dose.

The approval was based on data from a late-stage study,

which showed that the subcutaneous form of the drug was not

inferior to the intravenous formulation in patients with

advanced kidney cancer who have received prior systemic therapy.

The drugmaker is relying on newer treatments like Opdivo

Qvantig to drive growth as patents on older drugs, such as

cancer drug Revlimid and blood thinner Eliquis, expire later

this decade.

Opdivo Qvantig was co-formulated with Halozyme Therapeutics' ( HALO )

drug delivery technology, which helps reduce treatment

administration from hours-long IV infusions to subcutaneous

injections delivered in minutes.

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