JIDEYTRO (Zidesamtinib) Tablets

JIDEYTRO (zidesamtinib), from Nuvalent, Inc., is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received a prior ROS1 kinase inhibitor.

The recommended dose is 100 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity. In the ARROS-1 trial (NCT05118789) of 117 previously treated patients, the overall response rate was 44% (49% in patients with one prior ROS1 TKI and 38% in patients with two or more prior ROS1 TKIs).

• Central nervous system adverse reactions, including dizziness, ataxia, and cognitive and psychiatric disorders, can occur; treatment may need to be withheld, reduced, or discontinued based on severity.
• QTc interval prolongation can occur; ECGs and electrolytes should be evaluated before starting and monitored periodically during treatment.
• Interstitial lung disease (ILD)/pneumonitis can occur; patients should be monitored for new or worsening pulmonary symptoms, and treatment withheld immediately if ILD is suspected.
• Skeletal fractures can occur; patients with signs or symptoms of a fracture should be evaluated promptly.
• Myalgia with creatine phosphokinase (CPK) elevation can occur; serum CPK should be monitored and unexplained muscle pain or tenderness reported.
• Pancreatic toxicity can occur; amylase and lipase should be evaluated before starting and monitored periodically.
• Embryo-fetal toxicity: can cause fetal harm; effective contraception is advised. Breastfeeding is not advised, and treatment may impair fertility.
• Avoid concomitant use with strong or moderate CYP3A inhibitors and inducers.
• Most common adverse reactions (15% or more): edema, peripheral neuropathy, constipation, fatigue, and dyspnea.

What documents are required to import JIDEYTRO to India?

JIDEYTRO may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered oncologist
• Diagnostic report confirming ROS1-positive NSCLC and prior ROS1 kinase inhibitor treatment
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is JIDEYTRO available in India?

JIDEYTRO was approved in the US in July 2026 and may not yet be commercially available in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source JIDEYTRO from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For JIDEYTRO cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA — July 22, 2026 (Orphan Drug designation).

What is JIDEYTRO used for?

JIDEYTRO treats adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor.

Who manufactures JIDEYTRO?

JIDEYTRO is manufactured by Nuvalent, Inc.

How is JIDEYTRO taken?

One 100 mg dose by mouth once daily, with or without food, until disease progression or unacceptable toxicity.

How much does JIDEYTRO cost in India?

Cost depends on treatment duration and sourcing logistics — share your prescription with IPN for a quote.

When was JIDEYTRO approved by the FDA?

The FDA approved JIDEYTRO on July 22, 2026.