What Is Capivasertib (Truqap)? FDA Approval, Authorization and Reimbursement Status in Turkey

What Is Truqap (Capivasertib)?

Containing the active ingredient capivasertib , Truqapis a new-generation treatment targeting intracellular signaling pathways that are critical to cancer cell growth and survival: a targeted precision medicine. It is classified as a serine/threonine kinase inhibitor (AKT inhibitor) and was developed to directly suppress tumor cells with specific genetic alterations, particularly in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.

How Much Does Truqap Cost?

How Does Truqap Work?

Truqap acts within the signaling pathway that controls uncontrolled cancer cell proliferation, survival and metabolism, PI3K/AKT/mTOR , whose central component is the AKT (AKT1, AKT2 and AKT3 isoforms) protein, which the drug directly and potently inhibits.

The drug's main cellular effects are:

• Blocking the Signaling Pathway: It stops the signaling circuit that becomes overactive because of cancer cell mutations by binding to the ATP-binding site. Interrupting downstream signals slows tumor growth.
• Triggering Programmed Cell Death (Apoptosis): Normally, AKT prevents cancer cells from dying. When Truqap inhibits AKT, cell-death mechanisms are reactivated and tumor cells begin to destroy themselves.
• Cell-Cycle Arrest: By disrupting cancer cell division phases (G1 or G2/M), it limits tumor progression and the ability to metastasize.

Which Cancers Is Truqap Used to Treat?

Truqap is used in patients with a specific molecular profile who have developed resistance to standard therapies, in combination with fulvestrant (Faslodex) endocrine therapy in the following patient group:

Is Truqap Authorized and Reimbursed by SGK in Turkey?

What Are Truqap's Dose, Treatment Duration and Regimen?

Truqap is an oral film-coated tablet. To minimize drug accumulation and related side effects, a special intermittent dosing schedule (4/3 cycle) is used:

• Standard Dose: 400 mg twice daily (2 tablets of 200 mg in the morning and 2 tablets of 200 mg in the evening).
• Dosing Schedule: Take the drug on 4 consecutive days each week, followed by a 3-day break. For example, take it on Monday, Tuesday, Wednesday and Thursday; take none on Friday, Saturday or Sunday.
• Treatment Cycle: This pattern repeats in 28-day periods. Each cycle includes 16 treatment days and 12 days off. Treatment continues until disease progression or intolerable side effects.
• May be taken with or without food. It is rapidly absorbed and reaches its highest blood level within 0.5 - 4 hours.

What Are Truqap's Side Effects?

The main adverse events and frequencies identified in the biomarker-positive subgroup of CAPItello-291, related to the mechanism of AKT inhibitors, are:

Monitoring During Treatment and Key FDA-Approved Warnings

• Hyperglycemia (High Blood Sugar): The AKT signaling pathway is directly linked to insulin function. Inhibiting it may rapidly and substantially raise blood sugar. In patients with a history of diabetes or prediabetes, glucose monitoring before and during treatment is vital; antidiabetic treatment should be adjusted promptly if needed.
• Severe Diarrhea and Dehydration: Diarrhea, occurring in more than 70% of patients, can cause fluid and electrolyte loss (low potassium and sodium) and acute kidney dysfunction. Supportive treatment, including adequate hydration and appropriate medication, should begin as soon as diarrhea starts. In severe cases, Truqap should be interrupted or its dose reduced.
• Severe Skin Reactions: Severe rashes and dermatological conditions such as erythema multiforme may develop during treatment. Depending on severity, temporary interruption or permanent discontinuation may be necessary.
• Liver and Complete Blood Count Monitoring: Liver enzymes (AST/ALT), hemoglobin and lymphocyte levels should be closely monitored through periodic blood tests during treatment.
• Embryo-Fetal Toxicity: The drug carries a risk of serious harm to the embryo. Women of reproductive potential should use effective contraception during treatment and for a specified period after the last dose. Breastfeeding should be stopped entirely during treatment.
• Drug Interactions (CYP3A4): Truqap is metabolized in the liver mainly through CYP3A4. Strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin and grapefruit juice, may markedly increase drug exposure and the risk of adverse effects. Strong inducers, such as rifampicin, carbamazepine and St. John's wort, may lower blood levels and reduce effectiveness.

How Does Resistance to Truqap Develop?

Cancer cells may develop resistance mechanisms, or escape routes, against targeted molecules over time:

• Activation of Parallel Pathways: When AKT is blocked, cancer cells may survive by overactivating parallel signaling pathways such as RAS/RAF/MEK/ERK , reducing their dependence on the drug.
• Upstream Mutations: New mutations in RTKs (receptor tyrosine kinases) or mTOR, located upstream of the drug-binding site, may continue sending growth signals to tumor cells despite the blockade.
• Cellular Pump System (Efflux): Cancer cells may increase P-glycoprotein (P-gp) on their surfaces, pumping Truqap molecules out of the cell and reducing the drug's effect.
• Cellular Transformation (EMT): Cells are known to escape targeted therapies by acquiring more aggressive, resistant and stem-cell-like features through epithelial–mesenchymal transition.