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ANVISA Updates: Breakthrough Oncology and Pediatric Approvals in Brazil | JUly 2026

  • Badari Andukuri
  • 10 minutes ago
  • 3 min read

Ocrelizumab Secures Expanded Approval for Pediatric Multiple Sclerosis

Roche has received authorization to expand the use of ocrelizumab for children and adolescents aged 12 and older with relapsing-remitting multiple sclerosis. Patients must weigh at least 40 kilograms to qualify. Pediatric MS is rare but highly inflammatory and can severely affect cognitive and social development. This regulatory green light relies on the Phase III OPERETTA 2 trial, which proved the monoclonal antibody was highly effective at minimizing new brain lesions and reducing relapse rates compared to older therapies.

Merck's blockbuster immunotherapy pembrolizumab is now approved alongside belzutifan for adult patients battling clear cell renal cell carcinoma. This adjuvant therapy targets individuals at high risk of relapse following the surgical removal of a kidney or metastatic lesions. The Phase 3 LITESPARK-022 trial backed this decision, highlighting a 28 percent drop in the risk of recurrence or death compared to using the immunotherapy alone.

For adults facing relapsed or refractory diffuse large B-cell lymphoma who cannot undergo stem cell transplants, a new combination therapy is now available. Regulators have approved glofitamab combined with gemcitabine and oxaliplatin. As a bispecific antibody, glofitamab binds to both tumor cells and T cells to trigger a targeted immune attack. Data from the STARGLO study revealed a median overall survival of 25.5 months for this combination, doubling the survival time seen in the control group.

Pediatric patients as young as five years old with active systemic lupus erythematosus now have a new subcutaneous treatment option. Belimumab has been approved as an add-on therapy for children experiencing high disease activity despite standard care. The subcutaneous pen format allows families to administer the medication at home, saving them frequent trips to infusion clinics and improving overall quality of life.

Sanofi has gained approval for Fluprevli, a newly formulated trivalent influenza vaccine designed for anyone six months and older. In a major shift guided by global health authorities, this version removes the B/Yamagata strain, which has not been detected globally since early 2020. The updated shot provides robust protection against currently circulating influenza A and B viruses.

Patients with HER2-positive breast cancer who still have residual invasive disease following pre-surgical treatment have a powerful new option. Daiichi Sankyo's trastuzumab deruxtecan is now approved for adjuvant use. The DESTINY-Breast05 trial showed that this antibody-drug conjugate slashed the risk of recurrence or death by 53 percent compared to standard therapies.

The therapeutic reach of tislelizumab has grown significantly with two new first-line indications for non-small cell lung cancer. It is now cleared for use alongside carboplatin and paclitaxel for squamous variations of the disease. Furthermore, it is approved with pemetrexed and platinum chemotherapy for non-squamous lung cancer patients exhibiting high PD-L1 expression.

Children as young as two years old suffering from moderate to severe Crohn's disease now have access to ustekinumab. This approval targets pediatric patients who have not responded well to traditional treatments. By blocking key inflammatory proteins, the drug demonstrated strong clinical remission rates in the UNITI Jr. study, giving families a vital new tool against this chronic digestive condition.

A groundbreaking perioperative treatment plan featuring enfortumab vedotin and pembrolizumab is now approved for muscle-invasive bladder cancer. Designed for patients ineligible for cisplatin chemotherapy, this combination is given before surgery and continued afterward. Clinical data from the KEYNOTE-905 trial showed it reduced the risk of disease progression or death by a staggering 60 percent compared to surgery alone.

Samsung Bioepis has secured registration for Obodence, a new biosimilar matching the reference product Prolia. This monoclonal antibody is approved to treat postmenopausal osteoporosis, bone loss linked to cancer therapies, male osteoporosis, and bone thinning caused by glucocorticoid medications. It is delivered in the same 60mg pre-filled syringe format as the original drug, offering a cost-effective alternative for bone health management.

















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