New Lung Cancer Treatment Gains Approval from Anvisa

The Brazilian Health Regulatory Agency, known as Anvisa, has officially approved a new drug named EMRELIS (telisotuzumab-vedotin) aimed at treating lung cancer. This medication is specifically designed for adults suffering from locally advanced or metastatic non-squamous Non-small Cell Lung Cancer (NSCLC) with wild-type epidermal growth factor receptor (EGFR) who have already undergone systemic therapy.

How EMRELIS Works

EMRELIS targets the c-Met protein, which is overexpressed in certain tumor cells. Once it locates and attaches to this protein on the surface of the cancer cells, it facilitates the release of Monomethyl Auristatin E (MMAE) into the cells. This action effectively prompts cancer cell death, providing a new treatment avenue for patients with limited options.

The Need for New Treatments

Lung cancer remains one of the most prevalent causes of cancer-related deaths globally, with non-small cell lung cancer (NSCLC) making up about 85% of all lung cancer cases. Of these, approximately 70% are identified as the non-squamous subtype. Patients with locally advanced or metastatic NSCLC often have a dire prognosis, especially after they have undergone chemotherapy and immunotherapy, leaving them with few treatment alternatives.

Clinical Study Success

The approval of EMRELIS® was largely substantiated by encouraging data from a Phase 2 clinical trial known as the Luminosity study (M14-239). This research focused on previously treated NSCLC patients and demonstrated an impressive 29.2% Objective Response Rate (ORR) in the total population studied. Notably, patients exhibiting high levels of c-Met overexpression achieved an even higher ORR of 34.5%, highlighting the potential for long-term benefits in a patient group that often faces significant challenges.

Other Recent Approvals

In addition to lung cancer treatments, Anvisa recently approved another medication, Poherdy (pertuzumab), for use in both metastatic and early-stage breast cancer treatment. When used in conjunction with trastuzumab and docetaxel, Poherdy is indicated for patients with HER2-positive metastatic or locally recurrent, unresectable breast cancer who have not previously received anti-HER2 therapy or chemotherapy. Furthermore, for early-stage breast cancer, it can be employed:

• As neoadjuvant therapy before surgery for high-risk patients, defined as having HER2-positive locally advanced, inflammatory, or early-stage breast cancer.
• As adjuvant therapy after surgery for HER2-positive early-stage breast cancer patients at heightened risk of recurrence.