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Thiotepa

Generic Name
Thiotepa
Brand Names
Tepadina, Thiotepa Riemser
Drug Type
Small Molecule
Chemical Formula
C6H12N3PS
CAS Number
52-24-4
Unique Ingredient Identifier
905Z5W3GKH
Background

N,N'N'-triethylenethiophosphoramide (ThioTEPA) is a cancer chemotherapeutic member of the alkylating agent group, now in use for over 50 years. It is a stable derivative of N,N',N''- triethylenephosphoramide (TEPA). It is mostly used to treat breast cancer, ovarian cancer and bladder cancer. It is also used as conditioning for Bone marrow transplantation. Its main toxicity is myelosuppression.

Indication

ThioTEPA is used a as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients. Also, when high dose chemotherapy with HPCT support it is appropriate for the treatment of solid tumours in adult and paediatric patients.

Associated Conditions
Adenocarcinoma of the Ovaries, Breast Adenocarcinoma, Papillary transitional cell carcinoma of bladder, Malignant effusion

FDA Approves Shorla Oncology's TEPYLUTE 100mg: First Ready-to-Dilute Multi-Dose Thiotepa for Breast and Ovarian Cancer

• The FDA has approved Shorla Oncology's TEPYLUTE 100mg/10mL, the first multi-dose formulation of thiotepa that remains stable for 14 days when properly stored, offering greater flexibility for healthcare providers. • TEPYLUTE's ready-to-dilute formulation eliminates the need for reconstitution of the traditional freeze-dried powder, potentially reducing preparation time and errors in treatment administration. • The approval addresses treatment needs for over 300,000 women diagnosed with breast cancer and approximately 20,890 with ovarian cancer annually in the U.S., marking Shorla Oncology's fourth product launch in the American market.

FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors

• The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab, for adult solid tumors previously approved for intravenous Opdivo. • CheckMate-67T trial data showed non-inferior pharmacokinetic exposures, similar efficacy, and comparable safety to intravenous Opdivo. • Opdivo Qvantig offers a faster 3-5 minute administration time, providing convenience and flexibility for patients. • The approval helps Bristol Myers Squibb maintain market share amid patent expirations and increasing biosimilar competition.

FDA Approves Imkeldi (Imatinib) Oral Solution for Certain Leukemias and Cancers

• The FDA has approved Imkeldi (imatinib) oral solution, the first liquid formulation of imatinib, for treating certain forms of leukemia and other cancers. • Imkeldi is indicated for chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), and gastrointestinal stromal tumors (GIST) in adults and children. • The oral solution offers precise dosing, a palatable strawberry flavor, and does not require refrigeration, improving adherence and accessibility for patients. • This approval marks Shorla Oncology's fourth FDA approval, advancing its mission to improve existing oncology treatments through formulation re-innovation.

FDA Approves Tepylute, a Ready-to-Dilute Thiotepa Formulation, for Breast and Ovarian Cancer

• The FDA has approved Tepylute, a ready-to-dilute formulation of thiotepa, for treating breast and ovarian cancer, addressing limitations of the previous powder form. • Tepylute simplifies drug preparation, enhances dosing accuracy, and reduces healthcare personnel's exposure to this hazardous drug during handling. • Developed by Shorla Oncology, Tepylute is their first in-house NDA approval, marking a significant advancement in their oncology drug pipeline. • The new formulation aims to improve efficiency and safety in clinical settings, offering a more convenient option for clinicians and patients.
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