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NEW DRUG UPDATE: Itovebi (Inavolisib) Approved for PIK3CA-Mutated Breast Cancer

What Is Itovebi?


Itovebi (inavolisib), developed by Hoffmann-La Roche, is a selective PI3K inhibitor now approved in 3 mg and 9 mg tablets for oral use. It’s indicated for the treatment of locally advanced or metastatic breast cancer in combination with palbociclib and fulvestrant, particularly in patients who have become resistant to endocrine therapy.

Indications

  • Endocrine-resistant
  • PIK3CA-mutated
  • Hormone receptor-positive
  • HER2-negative
  • Breast cancer (locally advanced or metastatic)
  • Used after recurrence following adjuvant endocrine treatment

How It Works


Itovebi selectively inhibits PI3K, a pathway involved in cancer cell growth and survival. By targeting PIK3CA mutations, Itovebi reduces tumor cell proliferation and promotes apoptosis (cell death). Its effectiveness is enhanced when used in combination with palbociclib and fulvestrant.

Dosage & Administration

  • 9 mg orally once daily
  • Can be taken with or without food
  • Swallow tablets whole (do not chew, crush, or split)
  • Continue until disease progression or unacceptable toxicity


Not recommended in patients with moderate to severe renal impairment.

Common & Serious Side Effects


Most Common:

  • Hyperglycemia
  • Stomatitis
  • Diarrhea
  • Fatigue
  • Thrombocytopenia
  • Nausea, rash, headache, decreased appetite


Most Serious:

  • Severe hyperglycemia (monitor A1C and fasting glucose)
  • Severe diarrhea, dehydration, acute kidney injury
  • Neutropenia, intestinal perforation, gastric ulcers, anal abscess
  • Increased ALT, decreased weight, bone pain, and rare carcinoma reports

Drug Interactions


No specific interaction studies have been conducted. However, the risk of CYP enzyme-related interactions is low, making Itovebi a potentially safe option alongside many other therapies.

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