What Is Apalutamide (Erleada)? FDA Approval, Licensing in Turkey, and Reimbursement

• FDA Approved: Yes (First approval date: February 14, 2018)
• Brand Name: Erleada
• Active Ingredient: Apalutamide
• Route of Administration: Oral (tablet)
• Class: Nonsteroidal antiandrogen
• Category: Hormonal medicine
• Manufacturer: Janssen (Johnson & Johnson)
• Distribution in Turkey: Johnson and Johnson Sıhhi Mal. San. ve Tic. Ltd. Şti.
• Cancers for Which It Is Approved:
  • Nonmetastatic castration-resistant prostate cancer
  • Metastatic castration-sensitive prostate cancer

What Is Erleada?

Erleada contains apalutamide, a nonsteroidal antiandrogen that binds to androgen receptors (AR), inhibiting their movement to DNA and AR-mediated transcription. This biological mechanism prevents prostate cancer cells from growing and multiplying.

How Does It Work?

Apalutamide is an inhibitor that binds to androgen receptors , preventing androgens such as  testosterone  from binding to them. Normally, testosterone binds to these receptors, triggering gene expression within the cell and sending signals that accelerate cell division. Prostate cancer cells have become dependent on this process.

When apalutamide binds to the receptors:

1. Androgen binding  is blocked.
2. Transport of androgen receptors into the nucleus  is inhibited.
3. Interaction with DNA and gene transcription  are halted.

FDA (United States Food and Drug Administration) Approval History:

• February 14, 2018: It received its first FDA approval, for nonmetastatic castration-resistant prostate cancer.
• September 17, 2019: FDA approval was granted for metastatic castration-sensitive prostate cancer.

Licensing in Turkey:

It is approved by Turkey's Ministry of Health for the following licensed indications:

ERLEADA is indicated for adult men with nonmetastatic castration-resistant prostate cancer (moKDPK), an ECOG performance status of 0-1, and a high risk of metastatic disease (PSA doubling time ≤ 10 months, No-1, and PSA above 2 ng/dl).

ERLEADA is indicated with androgen deprivation therapy (ADT) for adult men with hormone-sensitive metastatic prostate carcinoma (mHDPK) without visceral metastases.

Is It Reimbursed?

The circumstances in which Erleada, containing apalutamide, is reimbursed by Turkey's Social Security Institution (SGK) are:

ERLEADA FILM-COATED TABLETS 60 mg, 120 tablets: Summary of Turkey's Healthcare Implementation Communiqué (SUT)

The Institution reimburses its use in adult men with nonmetastatic castration-resistant prostate cancer (nmKDPK), an ECOG performance status of 0-1, and a high risk of metastatic disease (PSA doubling time ≤ 6 months, PSA above 2 ng/dl, testosterone at castration levels [<50 ng/dl], and no previous cytotoxic chemotherapy).

The Institution reimburses its use with androgen deprivation therapy (ADT) in adult men with metastatic hormone-sensitive prostate cancer (mHDPK) without visceral metastases.

At the end of the report's validity period, a new report issued to continue treatment must state that there has been no progression.

The Institution reimburses sequential use of medicines containing enzalutamide, apalutamide, and abiraterone only if off-label drug-use approval has been granted by Turkey's Ministry of Health.

Price: As of December 2025, the pharmacy retail price of Erleada film-coated tablets 60 mg, 120 tablets, is 64,464.67  Turkish lira. 

Mechanisms of Resistance:

• Low expression of the androgen receptor (AR).
• Reduced binding affinity for the medicine due to AR mutations.

Absorption:

It is absorbed orally with 100% bioavailability. Food delays absorption by approximately 2 hours.

Distribution:

Plasma protein binding is 96%.

Metabolism:

Apalutamide is metabolized in the liver by CYP3A4 and CYP2C8 into inactive metabolites. Of the medicine, 65% is excreted in urine and 24% in feces.

Dose Range:

Recommended dose: 240 mg orally each day, with or without food.

Drug Interactions:

• Interaction 1: Medicines that accelerate apalutamide metabolism, such as phenytoin and carbamazepine, may reduce its effectiveness.
• Interaction 2: Medicines that reduce apalutamide metabolism, such as ketoconazole and itraconazole, may increase toxicity.

Conditions Requiring Caution:

1. No dose reduction is needed in patients with mild or moderate liver problems. However, its effects in patients with severe hepatic impairment are not fully known.

2. No dose reduction is needed in patients with mild or moderate kidney problems. However, its effects in patients with severe renal impairment, those on dialysis, or those with end-stage kidney disease are not fully known.

3. Patients should be monitored regularly for bone fractures and fall risk.

4. Caution is required in patients at risk of seizures. If a seizure occurs during treatment, apalutamide must be permanently discontinued.

5. Patients should be monitored for hot flashes. Doctors may recommend medicines such as clonidine, megestrol acetate, or soy tablets to reduce this adverse effect.

6. Patients should be informed about sexual dysfunction and impotence (erectile difficulties).

Adverse Effects:

Reported adverse effects can be listed by frequency as follows:

Common (≥10%) Adverse Effects

1. Fatigue
2. Rash
3. Low white blood cell count (leukopenia/neutropenia)
4. Hypertension
5. Diarrhea
6. Joint pain (arthralgia)
7. Hot flashes
8. Loss of appetite (anorexia)

Adverse Effects Occurring in 1-10%

1. Weight loss
2. Loss of sensation or tingling in the hands and feet (paresthesia)
3. Nausea
4. Musculoskeletal pain
5. Dizziness
6. Falls
7. Thyroid dysfunction (hypothyroidism)

Rare Adverse Effects (0.1-1%)

1. Dry or cracked skin
2. Various skin reactions, such as severe reactions including Stevens-Johnson syndrome, although these are rare
3. Heart rhythm disturbances, such as QT prolongation

Very Rare (≤0.1%)

1. Convulsions (seizures)

Managing Adverse Effects

• Rashes may be treated with topical steroids or oral antihistamines in mild cases. Dose reduction may be needed in severe cases.
• Hypertension should be managed with regular blood pressure checks and antihypertensive treatment.
• Hypothyroidism may require treatment with levothyroxine in patients who develop it.

If adverse effects worsen substantially or affect quality of life during apalutamide treatment, the regimen should be reassessed. Adverse effects occur most frequently early in treatment and may decrease somewhat as patients adapt.