Health care professionals celebrate ‘milestone’ FDA approval for HER2-positive solid tumors
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Key takeaways:
- The FDA approved fam-trastuzumab deruxtecan-nxki for certain adults with HER2-positive tumors on April 5.
- Social media posts by HCPs about product approvals or launches declined 6% in April vs. March.
An analysis of global online conversations among health care professionals on social media in April revealed tremendous enthusiasm about FDA approval of a treatment for adults with advanced HER2-positive solid tumors.
The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) — a HER2-directed antibody-drug conjugate previously approved for breast cancer and gastric cancer indications — on April 5.
The indication applies to use of the agent by adults with unresectable or metastatic HER2-positive solid tumors who received previous systemic therapy and lack additional treatment options.
Health care professionals (HCPs) heralded the approval and expressed optimism about the new treatment option.
Vivek Subbiah, MD, of Sarah Cannon Research Institute described it as a “major milestone” in tissue-agnostic therapy and precision medicine, while oncologist Sarah Sammons, MD, of Dana-Farber Cancer Institute reposted an article in which she described the approval as “unprecedented.”
Joaquim Bellmunt, MD, PhD, of Dana-Farber Cancer Institute praised the approval for providing a “new option for bladder cancer and other tumor types.” A post by Toni K. Choueiri, MD, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, sharing a link to the approval also received significant attention from HCPs online.
Creation Healthcare — a leading digital insights consultancy — used CREATION Pinpoint to analyze 2,271 English-language posts on X (formerly Twitter) by 1,432 HCPs from April 1 to April 30 to identify key aspects of discussions about FDA approval or launch of pharmaceutical products.
Discussion related to the new indication for fam-trastuzumab deruxtecan-nxki came amid a broader 6% decline in the number of HCP posts discussing treatment approvals or launches compared with March.
On April 18, the FDA expanded the approval of alectinib (Alecensa, Genentech) to include adjuvant treatment of certain patients with anaplastic lymphoma kinase-positive non-small cell lung cancer.
HCPs on social media were pleased with the approval, with David Cooke, MD, FACS, of UC Davis Health describing it as a “big deal.”
Rami Manochakian, MD, FASCO, of Mayo Clinic in Florida expressed a similar sentiment, describing the approval as “big news” and highlighting the positive outcomes of the pivotal ALINA study, on which the FDA based approval.
David R. Gandara, MD, of UC Davis Health said after the approval that “the advances continue” in the oncogene-driven NSCLC space.
On April 22, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, ImmunityBio) plus Bacillus Calmette-Guerin (BCG) for treatment of certain patients with nonmuscle-invasive bladder cancer (NMIBC).
The indication applies to individuals with BCG-unresponsive NMIBC with carcinoma in situ.
Several HCPs expressed excitement on X about the launch of the treatment and its potential impact on the treatment paradigm.
Following the approval, more than 40 HCPs humorously commented on a post by Mark A. Lewis, MD, an oncologist with Intermountain Healthcare, in which he joked about the often unusual names given to oncology drugs.
The most shared stories from HCPs discussing product launches in April included an FDA press release about the approval of fam-trastuzumab deruxtecan-nxki and an American College of Cardiology news article about the approval of low-dose colchicine for atherosclerosis.
References:
- Better listening for better health. Available at: https://creation.co/. Accessed May 20, 2024.
- Vivek Subbiah, MD (@VivekSubbiah). April 5, 2024. X (Twitter).
- CURE Today (@cure_today). April 25, 2024. X (Twitter).
- Joaquim Bellmunt, MD, PhD (@OncoBellmunt). April 6, 2024. X (Twitter).
- Tony Choueiri, MD (@DrChoueiri). April 5, 2024. X (Twitter).
- David Cooke, MD, FACS (@DavidCookeMD). April 19, 2024. X (Twitter).
- Rami Manochakian, MD, FASCO (@RManochakian). April 18, 2024. X (Twitter).
- David Gandara, MD (@drgandara). April 18, 2024. X (Twitter).
- Patrick Soon-Shiong, MD (@DrPatSoonShiong). April 25, 2024. X (Twitter).
- Mark Lewis, MD (@marklewismd). April 23, 2024. X (Twitter).
- FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2. Published April 5, 2024. Accessed May 20, 2024.
- ImmunityBio announces FDA approval of Anktiva, first-in-class IL-15 receptor agonist for BCG-unresponsive non-muscle invasive bladder cancer (press release). Available at: https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/. Published April 22, 2024. Accessed May 20, 2024.
- Bisognano JD. Low-dose colchicine for atherosclerosis: Key points. Available at: https://www.acc.org/Latest-in-Cardiology/ten-points-to-remember/2024/04/15/14/43/low-dose-colchicine-for. Published April 15, 2024. Accessed May 20, 2024.
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