Merck and AstraZeneca get Lynparza OK in China for new indication; BARDA exercises first option with Marinus
AstraZeneca and Merck’s Lynparza is approved in China for yet another indication.
Chinese regulators approved the blockbuster cancer drug and PARP inhibitor as a first-line maintenance treatment for adults in several specific circumstances: with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to first-line platinum-based chemotherapy in combination with Avastin, and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.
The approval was based off the Phase III PAOLA-1 trial, where patients on Lynparza plus Avastin following response to a platinum-based chemotherapy saw a PFS improvement in patients with HRD-positive advanced ovarian cancer.
Some of those data were presented at ESMO, but overall survival results were not statistically significant.
Lynparza first got approved in China in 2019 as a first-line maintenance treatment for a form of ovarian cancer.
BARDA pays out $12.3 million to support US manufacturing of anti-seizure API
BARDA is making the next move on its two year deal with Marinus Pharmaceuticals.
Marinus announced Thursday that BARDA exercised its first contract option with the company, with the option being worth close to $12.3 million to boost US onshoring of manufacturing capabilities to make the active pharmaceutical ingredient (API) for anti-seizure med ganaxolone.
This contract option was exercised under an ongoing cost-share contract that BARDA shares with Marinus, awarded back in 2020 to support the development of IV ganaxolone to treat refractory status epilepticus. RSE is a type of seizure that lasts for at least five minutes, or more than one seizure in less than five minutes, that still continues despite treatment from at least one anticonvulsant drug.
Per the contract, the potential BARDA funding if the agency exercises all options is approximately $51 million, which includes up to $21 million in previously approved base-period funding, today’s $12.3 million, and up to $18 million more in the future.
Marinus added that the onshoring initiative could decrease the supply cost of the API by more than 30%.