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 all 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.