Bevacizumab is under clinical development by F. Hoffmann-La Roche and currently in the 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 Bevacizumab’s likelihood of approval (LoA) and phase transition for Transitional Cell Carcinoma (Urothelial Cell Carcinoma) took place on 13 Dec 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 Bevacizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Bevacizumab overview

Bevacizumab (Avastin) is a recombinant humanized monoclonal IgG1 antibody. It is formulated as solution, concentrate solution for intravenous route of administration. Avastin in combination with xeloda or paclitaxel is indicated for the treatment of metastatic breast cancer. In combination with cisplatin (or carboplatin) and etoposide, bevacizumab is indicated for the treatment of small-cell lung cancer. Avastin is used for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer (with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease) and glioblastoma, with interferon alfa. Avastin in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer, malignant glioma. It is also indicated for the treatment of persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan. In combination with paclitaxel it is used for the treatment of platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.  It is also indicated for the treatment of cervical cancer with standard chemotherapy (paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy). Avastin is also indicated in combination with chemotherapy, to treat patients with recurrent ovarian cancer (Advanced Ovarian cancer). Avastin either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, and in combination with atezolizumab for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. Avastin in combination with atezolizumab is indicated for the treatment unresectable hepatocellular carcinoma.

Bevacizumab (RG435) is under development for the treatment of metastatic hepatocellular carcinoma, non-small cell lung cancer, metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma (first and second line therapy), as first line therapy for epithelial ovarian, fallopian tube, primary peritoneal cancer and hepatocellular carcinoma, locally advanced/metastatic well-differentiated digestive endocrine tumors, urothelial cell carcinoma, malignant mesothelioma, melanoma as first line and second line therapy, nasopharyngeal carcinoma, appendiceal adenocarcinoma, relapsed or refractory neuroblastoma (second line), adjuvant breast cancer (BC) HER2 negative, oligodendroglioma, metastatic breast cancer first and second line therapy, epithelial ovarian, bile duct cancer (first line), endocrine tumors of the gastrointestinal tract, and renal cell carcinoma in Japan. Avastin in combination with Tarceva (erlotinib) is indicated for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)-activating mutations. It is also indicated in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian and non-small cell lung cancer. It is under development for the treatment of recurrent glioblastoma multiforme and malignant pleural mesothelioma. It is also under development for anal cancer, cervical cancer, vulvar cancer, vaginal cancer and penile cancer.

It was also under development for non metastatic bladder cancer, HER2+ breast cancer, adjuvant non small cell lung cancer (NSCLC), metastatic liver cancer, chronic lymphocytic leukemia (CLL), intracranial meningioma, endometrial cancer, neuroendocrine carcinoid carcinoma, locally advanced and/or metastatic pancreatic cancer, cervical cancer, relapsed/refractory multiple myeloma and for diffuse large B-cell lymphoma and as adjuvant therapy for HER2 positive breast cancer, glioblastoma multiforme first line and metastatic rhabdomyosarcoma, metastatic renal cell carcinoma and non-rhabdomyosarcoma soft tissue sarcoma.

F. Hoffmann-La Roche overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

Quick View Bevacizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Bevacizumab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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.