The FDA has approved a new injectable version of cancer drug Keytruda as Merck seeks to protect its market dominance.
Here are five things to know:
- The approved shot is Keytruda Qlex, a widely used immunotherapy pembrolizumab. The shot can be administered in one minute every three weeks or two minutes every six weeks compared to a 30-minute intravenous infusion, according to a Sept. 19 news release from the drugmaker. The injection is approved for 38 solid tumor indications.
- A phase 3 clinical trial in patients with metastatic non-small cell lung cancer showed that the subcutaneous version had comparable levels and tumor response rates to the IV formulation. However, there were no notable differences in progression-free or overall survival.
- While the shot does not improve clinical outcomes relative to the IV version, it offers time savings and added flexibility where it can be administered, the release said. Hospitals could also benefit by freeing up infusion chairs, The New York Times reported Sept. 19.
- With IV Keytruda patents set to expire as early as 2028, Merck’s injectable version could also extend market exclusivity. The practice, “product hop,” involves tweaking a drug to secure new patents before generics enter the market. In previous years, drugmakers have carried out product hops for several expensive cancer drugs including Herceptin, Darzalex and Opdivo. However, some critics argue this delays access to lower-cost alternative medications.
- Keytruda currently costs $204,000 per year with the majority of the cost covered by government programs such as Medicare. Merck said the price of the new shot will be similar, with final pricing details expected soon. Since the medications launch in 2014, Keytruda has amassed $146 billion in sales and accounts for nearly half of Merck’s revenue.
