Trial Profile
A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 08 Dec 2021
Price :
$35
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At a glance
- Drugs Panobinostat (Primary) ; Bortezomib; Dexamethasone
- Indications Multiple myeloma
- Focus Registrational; Therapeutic Use
- Acronyms PANORAMA-1
- Sponsors Novartis
Most Recent Events
- 30 Nov 2021 According to a Secura Bio media release, FARYDAK will no longer be discussed at the December 2, 2021 meeting of the Oncologic Drugs Advisory Committee and the company anticipates FDA publishing a Federal Register notice announcing withdrawal of the approval.
- 30 Nov 2021 According to a Secura Bio media release, the company noted that as previously discussed with FDA, it was not feasible for the company to complete the required post-approval clinical studies as designed as part of the accelerated approval process because those studies were required to verify and describe the clinical benefit of the drug product, the clinical benefit of FARYDAK has not been confirmed under the specific constraints of the accelerated approval process.
- 30 Nov 2021 According to a Secura Bio media release, the company has submitted to FDA for the withdrawal of the approval of NDA 205353 for FARYDAK (panobinostat) oral capsules, based on discussions with the U.S. Food and Drug Administration (FDA).