Tags : Accelerated Approval

Karyopharm’s Xpovio (selinexor) Receives FDA’s Accelerated Approval for Relapsed/Refractory Multiple

Shots: The accelerated approval is based P-IIb STORM study results assessing Xpovio (80mg) + dexamethasone (20mg) in 122 patients with RRMM, prior treated with 4 therapies with the refractory disease to at least two proteasome inhibitors, immunomodulatory agent and anti-CD38 mAb The P-II STORM resulted in 25.3% overall response rate (ORR) in the subgroup of […]Read More

Genentech’s Venclexta (venetoclax) Receives FDA’s Accelerated Approval for Patients with

Shots: The accelerated approval is based on M14-358 (P-Ib) & M14-387 study (I/II) results assessing Venclexta (400mg qd) + azacitidine & decitabine & Venclexta (600mg qd) + LDAC (low-dose cytarabine) respectively in patients with 1L AML. or for those ineligible for intensive induction CT aged ≥60 yrs. M14-358 & M14-387 study results: Venclexta + azacitidine […]Read More