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FDA Approves Oral Tx for Breast Cancer – Trugap

……..catching up on FDA approvals

The FDA recently approved a new ORAL therapy, Truqap (capivasertib) from AstraZeneca Pharmaceuticals (AZ), for co-administration with Faslodex (fulvestrant) for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Breast cancer is the most common cancer and one of the leading causes of cancer-related death worldwide. HR-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype, with more than 65% of tumors considered HR-positive and HER2-low or HER2-negative. Collectively, mutations in PIK3CA, AKT1 and alterations in PTEN occur frequently, affecting up to 50% of patients with advanced HR-positive breast cancer.

Published cost of Truqap oral tablets, in either 160 mg or 200mg strengths, is around $24,000 for a supply of 64 tablets. Approved dosage of Trugap is 400 mg orally taken twice daily for 4 days followed by 3 days off. That translates into 4 tablets per day, 16 per week over the 4 ‘on’ days, which therefore translates into 4 weeks of therapy in a 64 tablet bottle. Therapy may continue until disease progression or unacceptable toxicity.

Since approval, AZ has named Biologics by McKesson as its specialty pharmacy dispensing partner.

CLICK HERE for Prescribing Information


FDA approves capivasertib with fulvestrant for breast cancer  

CLICK HERE to read the FDA press release


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Another Biosimilar to Avastin – Avzivi

……..catching up on FDA Approvals The FDA recently approved a new infused therapy, Avzivi (bevacizumab-tnjn) from Bio-Thera Solutions, as a biosimilar to AVASTIN (bevacizumab). It did not receive

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