Doxorubicin hydrochloride is under clinical development by Johnson & Johnson and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase II drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 45% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Doxorubicin hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Doxorubicin hydrochloride overview
Pegylated liposomal doxorubicin (Doxil, Caelyx) is an anthracycline topoisomerase inhibitor isolated from Streptomyces peucetius var. caesius. Doxil is encapsulated in the Stealth liposomes and follows lipid nanoparticle (LNP) drug delivery system. It is formulated as concentrate suspension pegylated liposomal injection for intravenous infusion administration. It is used for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy, metastatic breast cancer and it is also used for the treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. In combination with bortezomib, Doxil is used for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
It is under development for the treatment of HER2 negative and positive breast cancer as a adjuvant therapy. It was under development for the treatment of metastatic breast cancer as a first line therapy in the United states.
Johnson & Johnson overview
Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products and medical devices. The company conducts business through its operating companies. It provides pharmaceuticals for immune disorders, cancer, neurological disorders, infectious, cardiovascular, and metabolic diseases; and medical devices for use in cardiovascular, orthopaedic, neurovascular care, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, healthcare professionals and hospitals. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US) and Latin America. J&J is headquartered in New Brunswick, New Jersey, the US.
For a complete picture of Doxorubicin hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
