5 Hot FDA Approval Dates That Made Waves Across Therapeutic Areas in July

The FDA maintained its momentum in July, issuing a wave of drug approvals across diverse therapeutic areas, including oncology, cardiology, dermatology, and rare diseases.

The timeline below highlights 5 key dates from the past month when new treatment options were made available for various patient populations.

The FDA approved multiple groundbreaking treatments in July, enhancing options across patient populations. | Image Credit: Tada Images - stock.adobe.com

July 2 - FDA Approves Linvoseltamab to Treat R/R Multiple Myeloma and Sunvozertinib in Non–Small Cell Lung Cancer

The FDA kicked off the month by issuing 2 approvals, the first being for linvoseltamab (Lynozyfic; Regeneron), a B-cell maturation antigen bispecific antibody, indicated for adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy.1

This approval was based on results from the ongoing phase 1/2 LINKER-MM1 trial (NCT03761108), which showed robust and durable responses in a heavily pretreated population. The overall response rate (ORR) among the 117 participants who received a 200 mg dose of linvoseltamab was 70%, with 45% achieving a complete response or better.1

Regarding safety, 46% of patients experienced cytokine release syndrome, though most cases were mild and resolved within a median of 14.7 hours. Despite this adverse effect, Hans Lee, MD, a LINKER-MM1 investigator, expressed strong support for the therapy to The American Journal of Managed Care® (AJMC).2

"The approval of linvoseltamab is important because it really provides a very highly effective off-the-shelf therapy for the treatment of relapsed/refractory multiple myeloma," he said.2

That same day, the FDA granted accelerated approval to sunvozertinib (Zegfrovy; Dizal) as the first and only targeted oral treatment for patients with non–small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations; it is indicated for patients whose disease has progressed during or after platinum-based chemotherapy.3

The approval of sunvozertinib was supported by data from the WU-KONG1 Part B study (NCT03974022). The objective response rate of 107 patients who received 300 mg of sunvozertinib daily was 53.3%, and 66.7% continued to respond after a median follow-up of 7 months.3

"The US approval of [sunvozertinib] marks a landmark in scientific advancement and represents a meaningful milestone in addressing the long-standing unmet medical needs of this underserved patient population,” Pasi A. Jänne, MD, PhD, lead principal investigator of the WU-KONG1B Part B trial, said in a statement.4

July 7 - FDA Approves Sebetralstat for Hereditary Angioedema

Five days later, the FDA approved sebetralstat (Ekterly; KalVista Pharmaceuticals), a plasma kallikrein inhibitor, for the on-demand treatment of patients aged 12 and older with hereditary angioedema, an inherited genetic disorder characterized by recurrent episodes of severe swelling.5

The approval was based on results from the phase 3 KONFIDENT trial (NCT05259917) and its open-label extension, KONFIDENT-S (NCT05505916). In the KONFIDENT trial, 136 patients were randomized to receive sebetralstat, either as two 300-mg tablets or one 300-mg tablet, or a placebo.5

The median (IQR) time to first symptom relief was 1.61 (0.78-7.04) hours for the 300-mg dose cohort (P < .001) and 1.79 (1.02-3.79) hours for the 600-mg dose cohort (P = .001), compared with 6.72 (1.34 to >12) hours for the placebo cohort. Additionally, rates of complete resolution within 24 hours were 42.5% for the 300-mg group, 49.5% for the 600-mg group, and 27.4% for the placebo group.5

Data from the KONFIDENT-S extension trial showed even faster symptom relief, including a median time of 1.3 hours for laryngeal or abdominal attacks. Also, patients receiving long-term prophylaxis experienced rapid response to breakthrough attacks, with the option to self-treat within 10 minutes.5

"Until now, on-demand treatment relied on injectable subcutaneous or intravenous administration, often resulting in delayed intervention,” Marc A. Riedl, MD, a KONFIDENT investigator, said in a statement. “Having an oral option empowers patients to treat attacks early, which aligns with treatment guidelines and advances our goal as physicians to reduce the overall burden of disease.”6

July 14 - FDA Approves Finerenone for Heart Failure With Mildly Reduced or Preserved LVEF

One week later, the FDA approved finerenone (Kerendia; Bayer), a nonsteroidal mineralocorticoid receptor antagonist, for the treatment of heart failure with a left ventricular ejection fraction (LVEF) of at least 40%.7 The approval was based on results from the phase 3 FINEARTS-HF trial (NCT04435626).

Over a median follow-up of 32 months, patients treated with 20 or 40 mg of finerenone daily (n = 3003) experienced a statistically significant reduction in the composite end point of cardiovascular death and total heart failure events compared with those receiving placebo (n = 2998). A total of 1083 events occurred among 624 patients in the finerenone group, compared with 1283 events among 719 patients in the placebo group.7

Finerenone was also associated with fewer total worsening heart failure events (842 vs 1024; rate ratio, 0.82; 95% CI, 0.71-0.94; P = .006) and a modest reduction in cardiovascular-related deaths (8.1% vs 8.7%; HR, 0.93; 95% CI, 0.78-1.11).7

“Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care,” Scott D. Solomon, MD, chair of the executive committee for the FINEARTS-HF study, said in a statement.8

July 24 - FDA Approves Delgocitinib for Moderate to Severe Hand Eczema

Next, the FDA approved delgocitinib (Anzupgo; LEO Pharma), making it the first and only topical cream specifically indicated for the treatment of moderate to severe hand eczema in adults.9

The approval was based on findings from 2 global phase 3 trials, DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101). Together, the trials evaluated 960 patients treated with either 20 mg/g delgocitinib cream or a vehicle cream applied twice daily. In DELTA 1, the ORR was 20% for delgocitinib vs 10% for cream vehicle (P = .006). Similarly, in DELTA 2, the rates were 29% vs 7% (P < .0001).9

“As the first and only FDA-approved treatment for [chronic hand eczema], [delgocitinib] represents an important advance for many patients,” Robert Spurr, MBA, executive vice president, North America, LEO Pharma, said in a statement.10

July 28 - FDA Approves Pegcetacoplan for Rare Kidney Diseases C3G and Primary IC-MPGN in Patients 12 and Older

The FDA closed out the month by approving pegcetacoplan (EMPAVELI; Apellis Pharmaceuticals) as the first treatment for patients 12 years and older with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), 2 rare and severe kidney diseases.11 The approval was supported by positive results from the phase 3 VALIANT trial (NCT05067127).

A total of 124 patients were randomized to receive either pegcetacoplan (n = 63) or placebo (n = 61) twice weekly for 26 weeks. The trial met its primary end point, as patients treated with pegcetacoplan showed a 68% reduction in their urine protein to creatinine ratio (P < .0001). They also achieved stabilization of kidney function, as measured by estimated glomerular filtration rate, and 71% demonstrated complete clearance of C3 complement staining intensity (nominal P < .0001).12

Carla Nester, MD, MSA, FASN, lead principal investigator of the VALIANT trial, told AJMC that the availability of this treatment for younger populations is especially important since the median patient age is 16.12

"This will be my first opportunity to actually treat the group of patients [in whom] the bulk of this disease is being expressed in," Nester said.

References

1. Klein HE. FDA approves linvoseltamab to treat R/R multiple myeloma. AJMC. July 2, 2025. Accessed August 8, 2025. https://www.ajmc.com/view/fda-approves-linvoseltamab-to-treat-r-r-multiple-myeloma
2. McCormick B. Linvoseltamab approval offers new off-the-shelf option for heavily pretreated multiple myeloma: Hans Lee, MD. AJMC. July 16, 2025. Accessed August 8, 2025. https://www.ajmc.com/view/linvoseltamab-approval-offers-new-off-the-shelf-option-for-heavily-pretreated-multiple-myeloma-hans-lee-md
3. Bonavitacola J. FDA approves sunvozertinib in non-small cell lung cancer. AJMC. July 7, 2025. Accessed August 8, 2025. https://www.ajmc.com/view/fda-approves-sunvozertinib-in-non-small-cell-lung-cancer
4. Dizal’s Zegfrovy (sunvozertinib) receives FDA accelerated approval as the only targeted oral treatment for non-small cell lung cancer with EGFR exon 20 insertion mutations. News release. Dizal. July 2, 2025. Accessed August 8, 2025. https://www.prnewswire.com/news-releases/dizals-zegfrovy-sunvozertinib-receives-fda-accelerated-approval-as-the-only-targeted-oral-treatment-for-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations-302497351.html
5. Shaw ML. FDA approves sebeltralstat for hereditary angioedema. AJMC. July 7, 2025. Accessed August 8, 2025. https://www.ajmc.com/view/fda-approves-sebetralstat-for-hereditary-angioedema
6. KalVista Pharmaceuticals announces FDA approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema. News release. BusinessWire. July 7, 2025. Accessed August 8, 2025. https://www.businesswire.com/news/home/20250702871458/en/KalVista-Pharmaceuticals-Announces-FDA-Approval-of-EKTERLY-sebetralstat-First-and-Only-Oral-On-demand-Treatment-for-Hereditary-Angioedema
7. McNulty R. FDA approves finerenone for heart failure with mildly reduced or preserved LVEF. AJMC. July 14, 2025. Accessed August 8, 2025. https://www.ajmc.com/view/fda-approves-finerenone-for-heart-failure-with-mildly-reduced-or-preserved-lvef
8. U.S. FDA approves Kerendia (finerenone) to treat patients with heart failure with left ventricular ejection fraction ≥40% following priority review. News release. Bayer. July 14, 2025. Accessed August 8, 2025. https://bayer2019tf.q4web.com/news/news-details/2025/U-S--FDA-Approves-KERENDIA-finerenone-to-Treat-Patients-With-Heart-Failure-With-Left-Ventricular-Ejection-Fraction-40-Following-Priority-Review/default.aspx
9. Shaw ML. FDA approves delgocitinib for moderate to severe hand eczema. AJMC. July 24, 2025. Accessed August 8, 2025. https://www.ajmc.com/view/fda-approves-delgocitinib-for-moderate-to-severe-hand-eczema
10. Anzupgo (delgocitinib) cream is now the first and only FDA-approved treatment for moderate-to-severe chronic hand eczema (CHE) in adults. News release. Business Wire. July 23, 2025. Accessed August 8, 2025. https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults
11. McCormick B. FDA approves pegcetacoplan for rare kidney diseases C3G, primary IC-MPGN in patients 12 and older. AJMC. July 28, 2025. Accessed August 8, 2025. https://www.ajmc.com/view/fda-approves-pegcetacoplan-for-rare-kidney-diseases-c3g-primary-ic-mpgn-in-patients-12-and-older
12. McCormick B. Pegcetacoplan offers promising new treatment approach for patients aged 12 and older with C3G, primary IC-MPGN: Carla Nester, MD, MSA, FASN. AJMC. August 1, 2025. Accessed August 8, 2025. https://www.ajmc.com/view/pegcetacoplan-offers-promising-new-treatment-approach-for-patients-aged-12-and-older-with-c3g-primary-ic-mpgn-carla-nester-md-msa-fasn