Our clinical development strategy for XPOVIO® has been to innovate with the purpose of helping difficult-to-treat patient populations and then expanding into larger patient groups and tumor types. The mechanisms of action of our novel nuclear export inhibitors target a foundational aspect of cancer biology which may allow them to be used against a very wide variety of different tumors. Our development began in hematologic malignancies and we have expanded our clinical trials into a variety of solid tumors.
We see our pipeline of products as a critical partner of choice to be combined with other cancer medicines in a host of different types of cancer and other serious diseases.
We began in 2008 with a vision of pioneering a new approach to treating patients with cancer and other serious diseases. Our novel approach to treating cancer involves targeting a cancer cell’s nucleus to prevent the development of a disease. For this reason, our name is based on the suffix ‘karyo’, which means nucleus.
In 2019, we received our first accelerated approval in penta-refractory multiple myeloma. We received a second accelerated approval in 2020 for relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL).
We received an expanded approval for XPOVIO in December of 2020 to now include patients with multiple myeloma as early as first relapse.
In 2020, we also had a successful phase 3 study in heavily pretreated patients with a rare tumor type called dedifferentiated liposarcoma.
We are undertaking numerous clinical trials with a bright future of potential FDA approvals yet to come.
Karyopharm works every day, innovating the science needed to improve the lives of patients with cancer.
Below is a brief timeline of our company history.
Company founded by Drs. Sharon Shacham and Michael Kauffman to develop potential new drugs which target the regulation of certain proteins in the cell nucleus as a way to treat cancer and other diseases
First evidence of anti-cancer activity of selinexor in mice
First patient treated with selinexor in a clinical trial
Karyopharm becomes publicly traded company with shares listed on Nasdaq
Selinexor receives first accelerated approval by FDA for patients with relapsed or refractory multiple myeloma (a form of blood cancer) under the brand name XPOVIO
XPOVIO receives second accelerated approval by FDA for patients with relapsed or refractory diffuse large B-cell lymphoma (another form of blood cancer)
Company completes successful phase 3 study in heavily pretreated dedifferentiated liposarcoma.
On December 18, XPOVIO received expanded approval in multiple myeloma, which fundamentally changes the commercial profile of XPOVIO and Karyopharm. The previous approval limited XPOVIO to roughly 6,000 patients with penta-refractory disease. The expanded approval increases XPOVIO as an option to more than 39,000 patients who have received at least one prior therapy (including the original 6,000).
- 2021 And Beyond
Karyopharm hopes to expand XPOVIO’s approved indications in the U.S. into earlier stage disease, in combination with other anticancer drugs, and in new tumor types (particularly solid tumor indications).
In March, the European Commission (EC) granted conditional marketing authorization for NEXPOVIO® (selinexor), in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. Selinexor has also recently received regulatory approval in Israel.
Our team works relentlessly every day to develop innovative drugs to help treat patients with certain blood cancers or solid tumor malignancies. Since our beginning, we have been committed to changing lives and defeating cancer through science and innovation.