Karyopharm Therapeutics Inc. (KPTI - Free Report) announced that the FDA has approved a label expansion of its marketed drug, oral Xpovio (selinexor), under accelerated pathway. The drug’s label is expanded to include adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
The approval was based on data from a phase II study — SADAL — evaluating a fixed 60 mg dose of Xpovio administered orally twice weekly for a four-week cycle. Data from the study showed that the drug achieved an objective response rate of 29% with 13% complete responses and 16% partial responses. Moreover, the duration of response was three months in 56% of responding patients, six months in 38% and 12 months in 15%.
Continued approval for Xpovio in r/r DLBCL may be contingent upon verification and description of clinical benefit in a confirmatory study. As part of the accelerated approval, the FDA has agreed that the XPORT-DLBCL-030 study could serve as the confirmatory study. The study will evaluate Xpovio added to a standard backbone immunochemotherapy of rituximab-gemcitabine-dexamethasone-platinum in patients with one to three prior treatments for DLBCL. The study is expected to start by the end of 2020.
The drug will be made available in the U.S. market immediately for this indication. The company is also planning to file a marketing authorization application (“MAA”) for Xpovio for r/r DLBCL in 2021.
Xpovio was already approved in combination with dexamethasone as a treatment for r/r multiple myeloma patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. This indication was also approved under accelerated pathway in July 2019. The company has already submitted an MAA seeking approval for this indication in Europe.
Meanwhile, Karyopharm has also submitted a supplemental new drug application seeking label expansion of Xpovio as a treatment for patients with multiple myeloma, after at least one prior line of therapy, in combination with Takeda’s (TAK - Free Report) proteasome inhibitor, Velcade (bortezomib) and low-dose dexamethasone.
The company is also evaluating the drug in several other mid-and later-phase clinical studies across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies in liposarcoma and endometrial cancer. It started a phase I/II study earlier this month to evaluate Xpovio in combination with standard-of-care therapy in patients with newly-diagnosed or recurrent glioblastoma.
Shares of Karyopharm have lost 0.9% so far this year compared with the industry’s decline of 5.2%.
In April, the company began a phase II study to evaluate a lower dose of Xpovio in hospitalized patients with severe COVID-19.
Meanwhile, several marketed drugs like Sanofi/Regeneron’s IL-6 inhibitor, Kevzara; Roche’s (RHHBY - Free Report) IL-6 inhibitor, Actemra; Incyte/Novartis’ JAK1/JAK2 inhibitor, Jakafi; AstraZeneca’s (AZN - Free Report) BTK inhibitor, Calquence; and Amgen’s PDE4 inhibitor, Otezla, among others, are being evaluated to treat respiratory complications associated with COVID-19, which is the need of the hour.
Karyopharm currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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