Palbociclib is under clinical development by Pfizer and currently in Phase II for Metastatic Colorectal Cancer. According to GlobalData, Phase II drugs for Metastatic Colorectal Cancer have a 34% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Palbociclib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Palbociclib overview

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 overview

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.

For a complete picture of Palbociclib’s drug-specific PTSR and LoA scores, buy the report here.


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.