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Karyopharm In Pursuit Of Wider Use Of Xpovio

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After winning FDA nod for Xpovio in the treatment of relapsed or refractory multiple myeloma, Karyopharm Therapeutics Inc. (KPTI) is now awaiting the FDA decision on the same drug for another indication - i.e., in relapsed/refractory diffuse large B-cell lymphoma.

Xpovio, which is given in combination with steroid medicine called Dexamethasone, received accelerated FDA approval in July 2019 for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody, i.e., for Penta-refractory multiple myeloma.

Launched in July 2019, the drug generated sales of $30.5 million last year and $16.1 million in the first quarter of 2020.

The second indication for which the Company is seeking accelerated approval for Xpovio is in the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, who have received at least two prior therapies. The FDA decision is expected on June 23, 2020.

The Company has also filed a supplemental New Drug Application, seeking FDA approval for Xpovio as a new treatment for patients with previously treated multiple myeloma.

Xpovio, proposed as a treatment for Penta-refractory multiple myeloma in Europe, is under review by the European Medicines Agency, and a decision is expected by late-2020.

Jefferies analyst Maury Raycroft expects Xpovio to bring in sales of $123 million this year, with the numbers steadily picking up and achieving blockbuster status by 2025.

Xpovio, also known as Selinexor, is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound that works by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. By its tumor suppressor function, the cancer cells are selectively induced to undergo apoptosis while normal cells are unharmed.

The drug is being explored in various other indications as well, the most advanced of which is unresectable dedifferentiated liposarcoma, under a phase III trial, dubbed SEAL. Top-line data from this trial is expected this year.

A low dose of Selinexor is also being evaluated as a potential treatment for COVID-19, and a phase II study in hospitalized patients with severe COVID-19 was initiated in April of this year. This study is expected to enroll approximately 230 patients at clinical sites in the U.S., Europe, and Israel, with results anticipated in August of this year.

The Company ended March 31, 2020, with total cash of $385.2 million.

KPTI has traded in a range of $5.14 to $29.61 in the last 1 year. The stock closed Friday's trading at $18.49, down 1.65%.

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