1. RINVOQ® received European Commission approval for treating giant cell arteritis

On April 08, 2025, AbbVie announced that the European Commission (EC) had granted approval to RINVOQ® for the treatment of adult patients with giant cell arteritis (GCA). GCA is an autoimmune disease affecting multiple locations, and RINVOQ® is an oral JAK inhibitor to reduce the inflammatory conditions. The EC approval is supported by data from the Phase 3 SELECT-GCA trial, where both primary and secondary endpoints were achieved. As for the primary endpoint, at week 52, 46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission, compared with 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen. For the secondary endpoints, there were reduced disease flare frequency (34.3% in treatment vs. 55.6% in placebo), Lower cumulative steroid exposure (median exposure of 1615 mg vs. 2882 mg), and higher sustained complete remission rate (37.1% in treatment vs. 16.1% in placebo) observed in the group with the new treatment combination.

Link: https://news.abbvie.com/2025-04-08-AbbVie-Announces-European-Commission-Approval-of-RINVOQ-R-upadacitinib-for-the-Treatment-of-Adults-with-Giant-Cell-Arteritis

2. FDA approved BMS’s Opdivo® plus Yervoy® as a first-line treatment for MSI-H or dMMR metastatic colorectal cancer

On April 08, 2025, BMS announced the U.S. FDA has approved Opdivo® (nivolumab, anti-PD-1) plus Yervoy® (ipilimumab, anti-CTLA-4) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The approval is based on results from the CheckMate-8HW trial. Opdivo plus Yervoy met the dual primary endpoints of progression free survival (PFS) when compared to Opdivo monotherapy across all lines of therapy and when compared to chemotherapy in the first-line setting, as assessed by Blinded Independent Central Review (BICR).

Opdivo plus Yervoy demonstrated a 38% reduction in the risk of disease progression or death vs. Opdivo monotherapy in immunotherapy-naïve patients across all lines of therapy. The median PFS was not reached with Opdivo plus Yervoy and was 39.3 months with Opdivo monotherapy. Opdivo plus Yervoy also met a key secondary endpoint, demonstrating superior overall response rate (ORR) compared to Opdivo monotherapy.

Moreover, the Opdivo plus Yervoy vs. chemotherapy arm showed that the combination regimen reduced the risk of cancer progression or death by 79% compared to chemotherapy in first-line patients. This arm also assessed the other dual primary endpoint of PFS, where median PFS was not reached with Opdivo plus Yervoy compared to 5.8 months with chemotherapy. PFS rates were numerically higher with Opdivo plus Yervoy vs. chemotherapy at 12- and 24-months (79% vs. 21% and 72% vs. 14%, respectively).

Link: https://news.bms.com/news/corporate-financial/2025/U-S--Food-and-Drug-Administration-Approves-Opdivo-nivolumab-plus-Yervoy-ipilimumab-as-a-Treatment-for-Patients-with-Previously-Untreated-Microsatellite-Instability-High-or-Mismatch-Repair-Deficient-Unresectable-or-Metastatic-Colorectal-Cancer1/default.aspx

3. FDA approved BMS’s Opdivo® plus Yervoy® as a first-line treatment for advanced liver cancer

On April 11, 2025, BMS announced that the U.S. FDA approved Opdivo® (nivolumab, anti-PD-1) plus Yervoy® (ipilimumab, anti-CTLA-4) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval is supported by the Phase 3 CheckMate-9DW trial evaluating the combination of Opdivo plus Yervoy compared to the investigator’s choice of tyrosine kinase inhibitor monotherapy (lenvatinib or sorafenib).

In the trial, the median overall survival (mOS) for Opdivo plus Yervoy was 23.7 months vs. 20.6 months with lenvatinib or sorafenib, reducing the risk of death by 21%. The trial also showed that Opdivo plus Yervoy demonstrated an overall response rate (ORR) of 36.1% compared to 13.2% of patients treated with lenvatinib or sorafenib. Longer median duration of response (mDOR) of 30.4 months was also observed in the combination therapy vs. 12.9 months in the control arm.

Link: https://news.bms.com/news/corporate-financial/2025/U-S--Food-and-Drug-Administration-Approves-Opdivo-nivolumab-plus-Yervoy-ipilimumab-as-a-First-Line-Treatment-for-Unresectable-or-Metastatic-Hepatocellular-Carcinoma/default.aspx

4. European Commission approved Johnson & Johnson’s subcutaneous RYBREVANT® (amivantamab) with LAZCLUZE® for EGFR-mutated NSCLC

On April 8, 2025, Johnson & Johnson announced that the European Commission (EC) has approved an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with advanced EGFR ex19del or L858R substitution, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

The approval is supported by positive results from the Phase 3 PALOMA-3 study, which demonstrated non-inferiority of pharmacokinetics and efficacy of SC amivantamab compared to IV amivantamab, both in combination with lazertinib, in patients with EGFR-mutated advanced or metastatic NSCLC after disease progression on osimertinib and platinum-based chemotherapy. Moreover, the rate of infusion-related reactions (IRRs) for patients treated with SC amivantamab combined with lazertinib was five-fold lower (13% vs 66%, respectively) and less severe than those with the IV formulation

Link: https://www.jnj.com/media-center/press-releases/european-commission-approves-subcutaneous-rybrevant-amivantamab-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer

5. Nipocalimab showed sustained symptom improvement and significant MG-ADL score reductions over 60 weeks in antibody-positive generalized myasthenia gravis

On April 8, 2025, Johnson & Johnson announced results from the Phase 3 study evaluating investigational nipocalimab in a broad population of antibody-positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG). Nipocalimab demonstrated a mean change in MG-ADL of -5.64 from the double-blind baseline after 60 weeks for study participants receiving nipocalimab and SOC, and -6.01  change for study participants who transitioned from placebo and SOC to nipocalimab and SOC. Moreover, patients in the nipocalimab plus SOC treatment group were four times more likely to sustain symptom improvement at 20 weeks compared to the placebo plus SOC group.

Link: https://www.jnj.com/media-center/press-releases/johnson-johnson-highlights-new-data-that-showcase-the-strength-of-nipocalimab-demonstrating-long-term-sustained-disease-control-in-adults-living-with-generalized-myasthenia-gravis-gmg

6. JNJ-2113 showed strong efficacy in adolescents with moderate-to-severe plaque psoriasis, with over 86% achieving clear or almost clear skin

On April 10, 2025, Johnson & Johnson announced updated icotrokinra (JNJ-2113) data from a Phase 3 ICONIC-LEAD trial in moderate-to-severe plaque psoriasis. The revealed results showed the performance of this drug in adolescent patients. Icotrokinra is an oral peptide that selectively blocks IL-23 in adults and adolescents 12 years of age and older.

At week 16,  84.1% of adolescent patients with once-daily icotrokinra achieved an Investigator’s Global Assessment (IGA)b score of 0/1, and 70.5% achieved a Psoriasis Area and Severity Index (PASI)c 90 response, compared to 27.3% and 13.6% receiving placebo, respectively. Further, at week 24, 86.4% of adolescents achieved IGA 0/1 (clear or almost clear skin) and 88.6% achieved PASI 90.

Link: https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill

7. Tolebrutinib significantly delayed disability progression in patients with non-relapsing secondary progressive multiple sclerosis

On April 8, 2025, Sanofi announced positive results from the phase 3 HERCULES study, demonstrating that tolebrutinib delayed disability progression in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS). The trial data showed that tolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP) by 31% compared to placebo. Moreover, the drug was generally well-tolerated across all arms of the studies for all participants.

Link: https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-08-17-11-11-3057931

8. IMDELLTRA® improved overall survival over standard chemotherapy in patients with small cell lung cancer (SCLC)

On April 11, 2025, Amgen announced Phase 3 DeLLphi-304 results evaluating IMDELLTRA® (tarlatamab-dlle) as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy. The study met its primary endpoint with improvements in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy. IMDELLTRA® is a bispecific T cell engager targeting DLL3-expressing SCLC cells and activating T cells via CD3 at the same time.

Link: https://www.amgen.com/newsroom/press-releases/2025/04/imdelltra-demonstrated-superior-overall-survival-in-small-cell-lung-cancer

9. European Commission approved DATROWAY® (datopotamab deruxtecan) for HR-positive, HER2-negative metastatic breast cancer

On April 8, 2025, Daiichi Sankyo and AstraZeneca’s DATROWAY® (datopotamab deruxtecan) has been approved in the EU for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. The approval followed the positive opinion of the CHMP of the EMA and was based on results from the TROPIONBreast01 phase 3 trial.

In the trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to the investigator’s choice of chemotherapy in patients with HR+, HER2- metastatic breast cancer. Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. The median duration of response (DoR) was 6.7 months in the DATROWAY arm compared to 5.7 months in the chemotherapy arm.

Link: https://www.daiichisankyo.com/files/news/pressrelease/pdf/202504/20250408_E2.pdf