Oncology Development Strategies: Considerable Commercial Potential but Specific Needs Must be Addressed
- Language: English
- Published: January 2013
- Region: Global
The rationale to develop a stable formulation of palifosfamide is strong: it is the active metabolite of ifosfamide, a well-established alkylating chemotherapy agent. Palifosfamide may spare patients from the toxicities of two other inactive ifosfamide metabolites while retaining its anti-tumor activity. A phase III trial of palifosfamide in first line soft tissue sarcoma (PICASSO III) is underway with progression-free survival results expected later this year. In this report, we review the evidence supporting palifosfamide’s development, the likelihood of clinical trial success, key regulatory hurdles as well as the commercial opportunity.
2. Treatment and prognosis of soft tissue sarcoma
3. Treatment of advanced or metastatic soft tissue sarcoma
1. Palifosfamide as a single-agent
2. Palifosfamide in combination with doxorubicin
3. Phase I
4. Phase II
5. On-going phase III
6. Phase III trial in small cell lung cancer
CLINICAL AND REGULATORY OPINION
1. The rationale supporting the development of palifosfamide
2. Ifosfamide is active in STS: what does this mean for palifosfamide?
3. Phase II trial of palifosfamide suggests antitumor activity
4. Palifosfamide offers a better safety profile than ifosfamide
5. Ziopharm initiate PICASSO III pivotal trial without FDA’s SPA
6. The two regulatory approval pathways
7. Is palifosfamide eligible for Accelerated Approval?
8. Is PFS a validated surrogate for overall survival in randomized front-line STS cancer trials?
9. The Votrient Precedent – Full approval based on PFS
10. Will palifosfamide succeed in the PICASSO III trial?
11. Is the MATISSE phase III trial in SCLC likely to succeed?
1. Revenue projection in STS
2. Revenue projections in other indications
3. Competitive landscape
- Threshold Pharmaceuticals
- Merck KgaA
- Ariad Pharmaeuticals,Glaxo-Smith Kline