Paclitaxel trevatide

Basilea announces U.S. FDA Orphan Drug Designation granted to lisavanbulin for the treatment of malignant glioma

Retrieved on: 
Thursday, July 29, 2021

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Basileas tumor checkpoint controller, lisavanbulin, for the treatment of malignant glioma (brain cancer).

Key Points: 
  • Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Basileas tumor checkpoint controller, lisavanbulin, for the treatment of malignant glioma (brain cancer).
  • Dr. Marc Engelhardt, Chief Medical Officer, commented: The Orphan Drug Designation of lisavanbulin by the U.S. FDA is an important milestone for the development of lisavanbulin.
  • Glioblastoma is associated with a poor prognosis and there are only very limited therapeutic options available.
  • Lisavanbulin, as a targeted treatment, could be a useful new approach to expand the treatment options for patients with this devastating disease.

WPD Pharmaceuticals’ Licensor Receives FDA Fast Track Designation for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme; WPD Poland Arranges Loans

Retrieved on: 
Monday, July 12, 2021

As previously reported, CNS had also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

Key Points: 
  • As previously reported, CNS had also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.
  • Receiving Fast Track Designation from the U.S. FDA is a significant achievement in the advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain.
  • Many patients have almost no meaningful options and thousands lose the fight against this cancer every year.
  • CNS recently announced the start of patient enrollment in its study of Berubicin for the treatment of recurrent glioblastoma multiforme.

Athenex Provides Update from FDA Type A Meeting Regarding Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer

Retrieved on: 
Tuesday, July 6, 2021

The FDA was supportive and encouraged the Company to continue development of oral paclitaxel and encequidar for the treatment of metastatic breast cancer.

Key Points: 
  • The FDA was supportive and encouraged the Company to continue development of oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
  • We continue to believe that, if approved, oral paclitaxel and encequidar has the potential to address a major unmet need in metastatic breast cancer.
  • Athenex is also developing oral paclitaxel and encequidar for the treatment of cutaneous angiosarcoma, for which it has received Orphan Drug Designation from the FDA.
  • Athenex also received Orphan Designations from the European Commission for oral paclitaxel and encequidar for the treatment of soft tissue sarcoma.

Lantern Pharma Announces Scientific & Preclinical Data Indicating Blood Brain Barrier Permeability for Drug Candidate LP-184 in Glioblastoma and Potentially Other CNS Cancers

Retrieved on: 
Tuesday, December 15, 2020

platform to transform drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, announced today new scientific data that substantiates blood brain barrier permeability (BBB) for its drug candidate LP-184.

Key Points: 
  • platform to transform drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, announced today new scientific data that substantiates blood brain barrier permeability (BBB) for its drug candidate LP-184.
  • GBM has a median survival rate of only 15 months and ranks among the most aggressive of human cancers.
  • The ability of a drug candidate to cross the blood brain barrier is of critical importance in treatment outcomes for CNS and brain cancers.
  • Many drugs fail in clinical trials because of their low blood brain barrier permeability.

Athenex Announces FDA Acceptance for Filing of U.S. NDA for Oral Paclitaxel and Encequidar in Metastatic Breast Cancer with Priority Review

Retrieved on: 
Tuesday, September 1, 2020

Additionally, the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • Additionally, the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • We are working diligently with the FDA on this Priority Review to bring Oral Paclitaxel to patients with metastatic breast cancer as quickly as possible, said Dr. Rudolf Kwan, Chief Medical Officer of Athenex.
  • Intravenous (IV) Paclitaxel is a foundational chemotherapy in multiple tumor types and we plan to invest in broadening the label and uses for Oral Paclitaxel.
  • The Oral Paclitaxel NDA submission is supported by data from a single pivotal Phase III study of Oral Paclitaxel for the treatment of metastatic breast cancer.