Palbociclib is under clinical development by Pfizer and currently in the Phase I, Phase II and Phase III 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 Palbociclib’s likelihood of approval (LoA) and phase transition for Metastatic Colorectal Cancer took place on 04 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Palbociclib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Palbociclib (Ibrance) is a pyridopyrimidine-derived cyclin-dependent kinase (CDK) inhibitor with high anti-neoplastic activity. It is formulated as hard gelatin capsules, tablets and film coated tablets for the oral route of administration. Ibrance is indicated in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Ibrance is also indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy, for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor, also in combination with fulvestrant in women who have received prior endocrine therapy.
Palbociclib (PD-0332991) is under development for the treatment of metastatic clear cell renal cell carcinoma, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), clear cell renal cell carcinoma (ccRCC) and papillary renal cell carcinoma (pRCC), pediatric diffuse intrinsic pontine glioma, medulloblastoma, neuroblastoma, glioblastoma, rhabdomyosarcoma, Ewing sarcoma, breast cancer (adjuvant therapy), metastatic HER2 positive and negative breast cancer, high risk early breast cancer, oligodendroglioma, non-small cell lung cancer, liposarcoma, anaplastic oligoastrocytoma, metastatic hepatocellular carcinoma , fallopian tube cancer, epithelial ovarian cancer, peritoneal cancer, chordoma, nonmelanomatous skin cancer, cervical cancer, bladder cancer, mantle cell lymphoma and acute myeloid leukemia, acute lymphoblastic leukemia, estrogen receptor positive advanced or recurrent endometrial cancer, metastatic castration-resistant prostate cancer, metastatic pancreatic cancer ductal carcinoma in situ of breast, androgen receptor positive breast cancer, triple negative androgen receptor positive breast cancer, relapsed and refractory acute myeloid leukemia and metastatic pancreatic ductal adenocarcinoma.
It was under development for myelodysplastic syndrome, gliosarcoma, glioblastoma multiforme (GBM), metastatic melanoma, relapsed and refractory multiple myeloma and metastatic urothelial carcinoma.
Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.
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