As Panobinostat moves closer to clinical approval for additional indication, what is the likelihood that the drug will be approved?

Panobinostat is under clinical development by Secura Bio and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Panobinostat’s likelihood of approval (LoA) and phase transition for Neuroblastoma took place on 15 Jul 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 15 Jul 2022 increased Panobinostat’s LoA and PTSR for Osteosarcoma.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Panobinostat LoA and PTSR Report.

Panobinostat overview

Panobinostat (Farydak) is a cinnamic hydroxamic acid analogue with potential antineoplastic activity. It is formulated as hard gelatin capsules for the oral route of administration. Panobinostat is indicated in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent.

Panobinostat (LBH589) is under development for the treatment of pediatric patients with diffuse intrinsic pontine glioma (DIPG), graft versus host disease (GVHD), sickle cell disease, HIV-1 infections. The drug candidate was also under development for the treatment of Huntington’s disease, hematological tumors such as thyroid cancer, multiple myeloma, acute myelocytic leukemia, myelodysplastic syndrome, diffuse large B-cell lymphoma, thrombocythaemia myelofibrosis, myelofibrosis, refractory cutaneous T-cell lymphoma, post-polycythemia vera myelofibrosis (PPV-MF), acute lymphocytic leukemia, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, recurrent high grade glioma, chronic lymphocytic leukemia (CLL), esophageal cancer, gastric cancer, colorectal cancer, head and neck cancer, Hodgkin lymphoma, small-cell lung cancer, adult T-cell lymphoma, mantle cell lymphoma, thyroid cancer, adult T-cell leukemia, chronic myelocytic leukemia, osteosarcoma, malignant rhabdoid tumor, atypical teratoid rhabdoid tumor (MRT/ATRT), and neuroblastoma, non-small cell lung cancer, hepatocellular carcinoma, metastatic melanoma, HER -2 positive metastatic breast cancer, neuroendocrine tumors, metastatic renal cell carcinoma, refractory chronic myelocytic leukemia and recurrent malignant gliomas.

Secura Bio overview

Secura Bio is a pharmaceutical company that develops innovative therapies and drugs. Its product portfolio includes FARYDAK (panobinostat) capsules, which are used for treating patients with multiple myeloma. Secura Bio is headquartered in Las Vegas, Nevada, the US.

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