Karyopharm Therapeutics Inc (NASDAQ:KPTI) achieved significant progress in making cancer patients’ lives better with the receipt of FDA approval for its drug – XPOVIO.
Approval for two oncology conditions
In 2020, Karyopharm received the US FDA nod for its drug XPOVIO for the treatment of patients suffering from multiple myeloma and DLBCL (refractory diffuse large B-cell lymphoma). CEO of Karyopharm, Michael G. Kauffman said the company is pleased with the addition of its three different combination regimens of XPOVIO into the NCCN (National Comprehensive Cancer Network)’s CPG (Clinical Practice Guidelines) in Oncology.
Focus on commercial expansion of XPOVIO
Kauffman said the company will focus on the commercial expansion of its drug – XPOVIO in 2021 for the third and second LTS (line treatment settings) of multiple myeloma. It helps to extend support for a significant patient population suffering from this disease.
The IMH (Israeli Ministry of Health) gave its nod in February 2021 for XPOVIO to treat patients with multiple myeloma. Karyopharm entered a pact with FORUS Therapeutics Inc in December 2020, for the commercialization of XPOVIO in Canada. As per the terms of the pact, the FORUS paid $5 million to Karyopharm.
Karyopharm will also get certain payments on achieving commercial and regulatory milestones. It is also eligible to receive additional royalties on net sales of XPOVIO in the future in Canada.
Expects EC regulatory decision for Nexpovio
Karyopharm expects to receive the regulatory nod of EC (European Commission) by April 2021 for the global expansion of its drug – NEXPOVIO. It is on the backdrop of receiving a positive opinion from CHMP (Committee for Medicinal Products for Human Use) for safe use on humans. The company is also advancing XPOVIO for the treatment of solid tumors and expects to post topline data in H2 2021 from its Phase 3 SIENDO clinical trial in endometrial cancer.
Karyopharm added Senior Vice President – Michael Mano, who will contribute over 15 years of experience in IP licensing, supporting partnerships, financing efforts, and corporate governance.
Karyopharm also recruited Chen Schor to its director board in December 2020. He played a vital role in leading the biotechnology companies.