Human beings are known to be good at a ton of different things, and yet the greatest ability you can find their arsenal is that tendency to grow on a consistent basis. This ability, in particular, has allowed us to hit upon some huge milestones, with technology sticking out as a member of the stated group. The reason why technology stands out from the rest is predicated upon its unique skill-set, which introduced us to all those possibilities that we could have never imagined otherwise. However, the whole runner was also, at the same time, inspired by how we applied the stated skills in a real-world setting. The latter component was, in fact, what gave the creation a spectrum-wide presence, including a timely appearance on our healthcare block. Technology’s foray into healthcare was so perfectly timed because it came right when the sector was beginning to struggle against its own obsolete structure. Fortunately, this reality was revamped under the new regime, but even after realizing such a massive feat, the medtech concept will jut continue producing all the right goods. The same has only turned more and more evident over the recent past, and a new FDA approval should do a lot to solidify its traces moving forward.
Fennec Pharmaceuticals, a medtech company based in North Carolina, has successfully earned FDA’s approval for its drug, Pedmark, which is designed to reduce the risk of hearing loss in patients receiving chemotherapy. Interestingly enough, the green light comes after two straight rejections, but now that it is here, the drug will be available for pediatric patients aged 1 month and older. Furthermore, these patients must be receiving a specific cisplatin-based chemotherapy for solid tumors that have not yet spread. The cisplatin, in general, is a platinum-centered therapy that can be used for treating a wide range of cancers. However, the toxic effects brought in to suffocate cancer cells have shown an additional tendency to spread across the body, and consequentially, cause serious side effects. Enter Fennec’s Pedmark. The drug is basically a proprietary formulation of sodium thiosulfate that interacts with cisplatin to produce an inactive form of platinum. Treating it as a launchpad, the drug goes on to spark activity across the relevant cells so to minimize the risk of chemo-induced hearing loss.
Fennec’s regulatory win is understood to come on the back of two open-label clinical trials. Boasting over 239 participants, these trials saw patients getting randomly assigned to receive either cisplatin, along with the Fennec drug dosed according to body weight, or just cisplatin alone. Both the trials proved that the prevalence of hearing loss was much lower in patients given Pedmark plus cisplatin compared to those treated with cisplatin alone.
“The FDA approval of PEDMARK represents an important breakthrough for pediatric patients with localized, non-metastatic solid tumors at risk for cisplatin-induced hearing loss. Cisplatin is a critical, standard of care agent, used in the treatment of pediatric cancers; however, even though effective, it could be harmful to children, frequently causing permanent and irreversible bilateral hearing loss. With PEDMARK, physicians now have an approved treatment option to reduce the risk of cisplatin-induced hearing loss in pediatric patients,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals.