1. U.S. FDA approved RINVOQ® for the treatment of giant cell arteritis

On April 29, 2025, Abbvie announced the U.S. FDA has approved RINVOQ® (upadacitinib), 15 mg for the treatment of adults with giant cell arteritis (GCA). GCA is an autoimmune disease that causes inflammation of the arteries, and RINVOQ® is a JAK inhibitor to suppress the immune activation. The approval was supported by the Phase 3 SELECT-GCA trial results. The study met the primary endpoint, where 46.4% of patients receiving RINVOQ® 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 to week 52, compared to 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen.

Link: https://news.abbvie.com/2025-04-29-RINVOQ-R-upadacitinib-Receives-U-S-FDA-Approval-for-Giant-Cell-Arteritis-GCA

2. Approval of IMAAVY™ by the U.S. FDA to treat generalized myasthenia gravis patients aged 12 years and older

On April 30, 2025, Johnson & Johnson announced that the U.S. FDA had approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody for the treatment of generalized myasthenia gravis (gMG). The approval was followed by the previous priority review and could benefit adults and paediatric patients over 12 years old who are anti-AChR or anti-MuSK positive

The approval is supported by data from the pivotal, ongoing Vivacity-MG3 study. IMAAVY plus standard of care provided superior disease control throughout 24 weeks when compared to the placebo group, as measured by improvement in the MG-ADLb score. The score evaluates key daily functions, such as chewing, swallowing, speaking and breathing.

The drug reduced autoantibody levels by up to 75% from the first dose till week 24.

Link: https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-approval-for-imaavytm-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg

3. Discontinuation of Phase III trial evaluating Truqap on castration-resistant prostate cancer

On April 29, 2025, AstraZeneca announced the discontinuation of CAPItello-280 Phase III trial which evaluates the efficacy and safety of Truqap (capivasertib) in combination with docetaxel and androgen-deprivation therapy (ADT) compared to docetaxel and ADT with placebo in patients with metastatic castration-resistant prostate cancer (mCRPC).

The Independent Data Monitoring Committee reviewed the data and concluded that the Truqap combination was unlikely to meet the dual primary endpoints of radiographic progression-free survival and overall survival. Truqap is an ATP-competitive inhibitor of all three AKT isoforms (AKT1/2/3) and has previously been approved for certain types of breast cancer.

Link: https://www.astrazeneca.com/media-centre/press-releases/2025/update-on-capitello-280-phase-iii-trial.html

4. CHMP recommended Calquence (acalabrutinib) in combination with venetoclax for the treatment of chronic lymphocytic leukaemia

On April 29, 2025, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Calquence (acalabrutinib) in combination with venetoclax, with or without Obinutuzumab to treat adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Calquence plus venetoclax with or without obinutuzumab demonstrated a 58% and 35% reduction in the risk of disease progression or death compared to standard-of-care chemoimmunotherapy, respectively. At three years, 77% of patients treated with Calquence plus venetoclax and 83% of patients treated with Calquence plus venetoclax and obinutuzumab were progression-free, versus 67% of patients treated with chemoimmunotherapy. Meanwhile, the median progression-free survival (PFS) was not reached for either experimental arm versus 47.6 months for chemoimmunotherapy.

Link: https://www.astrazeneca.com/media-centre/press-releases/2025/fixed-duration-calquence-recommended-in-eu-for-cll.html

5. Breztri achieved all primary endpoints in both Phase III KALOS and LOGOS trials for patients with uncontrolled asthma

On May 2, 2025, AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines in Phase III KALOS and LOGOS trials for patients with uncontrolled asthma. Breztri is an inhaled triple-combination therapy previously approved for the treatment of chronic obstructive pulmonary disease (COPD).

Link: https://www.astrazeneca.com/media-centre/press-releases/2025/breztri-met-primary-endpoints-in-ph3-asthma-trials.html

6. Mepolizumab showed positive results in managing COPD

On April 30, 2025, GSK announced positive results for Nucala (mepolizumab, an IL-5 blocker) in the treatment of chronic obstructive pulmonary disease (COPD). In the study, mepolizumab showed a clinically meaningful and statistically significant 21% reduction in the annualised rate of moderate/severe exacerbations versus placebo, meeting the primary endpoint. As the secondary endpoint, mepolizumab reduced 35% in the annualised rate of exacerbations that led to the emergency department. The drug has the potential to reduce hospitalisation in the management of COPD.

Link: https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-delivers-clinically-meaningful-and-statistically-significant-reduction-in-copd-exacerbations-with-positive-matinee-trial-results-published-in-nejm/

7. Zongertinib showed strong and durable responses in previously treated NSCLC with HER2-mutant

On April 28, 2025, Boehringer Ingelheim reported updated data from the Beamion LUNG-1 trial evaluating zongertinib in previously treated patients with HER2-mutant advanced non-small cell lung cancer (NSCLC). Zongertinib is an investigational irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR.

Among patients with HER2 mutation in the TKD domain, the objective response rate was 71%, with 7% complete response, 64% partial response, and 96% disease control in previously treated patients. The median duration of response was 14.1 months, and the median progression-free survival was 12.4 months. Moreover, zongertinib also had pharmacological effects in treated patients with brain metastasis, with 41% achieving responses and 81% disease control.  

Link: https://www.boehringer-ingelheim.com/human-health/cancer/lung-cancer/zongertinib-durable-clinically-meaningful-results-nsclc

8. Lynozyfic™ received EU conditional approval for heavily pretreated relapsed/refractory multiple myeloma

On April 28, 2025, Regeneron Pharmaceuticals announced that the European Commission had granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma. Before receiving this new therapy, the patients have to receive at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression after the last therapy. Lynozyfic is a bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

The EC approval is based on results from the pivotal LINKER-MM1 trial. Results showed a 71% objective response rate (ORR), with 50% of patients achieving a complete response (CR) or better. 41% of patients had no detectable minimal residual disease (MRD), and the median duration of response (DOR) was 29 months.

Link: https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-approved-european-union-treatment