The OncFive: Top Oncology Articles for the Week of 5/31

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

FDA Approves Orally Disintegrating Nilotinib Tablets for Chronic Myeloid Leukemia

The FDA has approved an orally disintegrating tablet formulation of nilotinib (Cavhanza) for the treatment of select patients with chronic myeloid leukemia (CML), with the formulation designed to maintain bioavailability and enable concomitant use of acid-reducing agents, such as proton pump inhibitors and/or H₂ antagonists, without timing restrictions.

This formulation of nilotinib is indicated for:

• Adult patients with newly diagnosed Philadelphia chromosome (Ph)–positive CML in chronic phase
• Adult patients with chronic and accelerated phase Ph-positive CML with resistance or intolerance to prior therapy, including imatinib (Gleevec)

FDA Grants Priority Review to Giredestrant for ER-Positive Early Breast Cancer

The FDA granted priority review to a new drug application (NDA) seeking the approval of giredestrant for the adjuvant treatment of adult patients with estrogen receptor (ER)–positive, HER2-negative, stage I to III breast cancer.

The Prescription Drug User Fee Act target action date is November 30, 2026. The application is backed by data from the phase 3 lidERA Breast Cancer trial (NCT04961996), which demonstrated that adjuvant giredestrant reduced the risk of invasive disease recurrence or death vs standard-of-care (SOC) endocrine therapy by 30% in patients with medium- or high-risk stage I to III ER-positive, HER2-negative early breast cancer (HR, 0.70; 95% CI, 0.57-0.87; P = .0014). At the 3-year landmark analysis, 92.4% of patients in the giredestrant arm were alive and free of invasive disease compared with 89.6% in the SOC endocrine therapy arm.

FDA Approves Companion Diagnostic for Inavolisib in HR+/HER2–, PIK3CA-Mutated Breast Cancer

The FDA has approved FoundationOne CDx for use as a companion diagnostic for inavolisib (Itovebi) in combination with palbociclib (Ibrance) and fulvestrant (Faslodex) in the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer.

The FDA previously approved the FoundationOne Liquid CDx for use as a companion diagnostic in the same indication in October 2024.

CELMoDs and Bispecifics Break Through Across Lymphomas and Leukemias at EHA 2026

The 2026 EHA Congress is less than a week away, and to help prepare for the meeting, check out some of the key lymphoma and leukemia abstracts experts are looking forward to seeing at the meeting.

Looking for more on EHA 2026? Check out our multiple myeloma preview here.

Advancing Bladder Cancer Care Through Education and Awareness

From the debut of non-platinum perioperative regimens in muscle-invasive disease to the first FDA approval of an immune checkpoint inhibitor combined with BCG in the non-muscle-invasive setting, the bladder cancer treatment landscape is evolving at a pace that experts describe as transformative.