Pharma Stock Roundup: FDA Approvals for LLY, MRK, AZN & JNJ Drugs

FDA Approves Lilly’s Eczema Drug Ebglyss

The FDA granted approval to Lilly’s Ebglyss for treating moderate-to-severe atopic dermatitis in adults and children aged 12 and above whose disease is not well controlled with topical prescription medicines. Ebglyss was approved in the European Union in 2023 and in Japan in January this year. Ebglyss’ approval for moderate-to-severe atopic dermatitis, also called eczema, was based on data from ADvocate 1, ADvocate 2 and ADhere studies. Data from these studies showed that patients treated with Ebglyss experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks.

FDA Approves Novartis’ Kisqali for Early Breast Cancer

The FDA granted approval to Novartis’ drug Kisqali for an early breast cancer indication. Kisqali can now be prescribed in combination with an aromatase inhibitor for the adjuvant treatment of patients with stage II and III HR+/HER2- early breast cancer who are at risk of recurrence, including those diagnosed with high-risk, node-negative. The approval is based on data from the pivotal phase III NATALEE study.

Earlier in the week, Novartis also announced updated data from the NATALEE study at the European Society for Medical Oncology. The data showed that Kisqali added to endocrine therapy (“ET”) led to a deepening disease-free survival benefit beyond the three-year treatment period, reducing the risk of recurrence by 28.5% compared to ET alone. This invasive disease-free survival benefit was consistent across all patient subgroups, including those with node-negative disease who have few treatment options beyond ET. Results were also consistent across secondary endpoints, including distant disease-free survival, with a notable trend towards improved overall survival.

Kisqali is under review in the EU and some other countries for early breast cancer. Kisqali is currently approved for treating HR+/HER2- metastatic breast cancer in several countries including the United States and EU.

FDA Approves AstraZeneca’s Fasenra for Autoimmune Disease

The FDA also granted approval to AstraZeneca’s asthma drug Fasenra for EGPA, a rare autoimmune disease that can cause damage to multiple organs and tissues. This is the second approved indication for Fasenra. The approval is based on data from the phase III MANDARA study. The head-to-head study compared a single monthly injection of Fasenra to three injections per month of GSK’s Nucala (mepolizumab), which is the only current approved drug for EGPA.

Fasenra is presently approved for treating severe eosinophilic asthma. Several label expansion studies are ongoing for Fasenra for eosinophil-driven diseases beyond severe asthma, like nasal polyps, chronic obstructive pulmonary disease, hypereosinophilic syndrome and others.

FDA Approves Merck’s Keytruda for Malignant Mesothelioma

The FDA granted approval to Merck blockbuster PD-L1 inhibitor Keytruda in combination with chemotherapy for the first-line treatment of patients with unresectable advanced or metastatic MPM. Pleural mesothelioma is a type of cancer that develops in the tissue that lines the lungs or pleura. The FDA approval was based on data from the pivotal phase II/III KEYNOTE-483 study. This approval marks the first indication for Keytruda in MPM.

Merck and Japanese partner Daiichi Sankyo’s HER3-directed DXd antibody drug conjugate, patritumab deruxtecan, demonstrated a statistically significant progression-free survival improvement in the HERTHENA-Lung02 study in previously treated EGFR-mutated non-small cell lung cancer (NSCLC).

The HERTHENA-Lung02 study evaluated the efficacy and safety of patritumab deruxtecan versus pemetrexed and platinum chemotherapy for treating locally advanced or metastatic EGFR-mutated NSCLC in patients who had received prior EGFR tyrosine kinase inhibitor treatment. Progression-free survival was the study’s primary endpoint. As regards overall survival, a key secondary endpoint of the study, the data were immature at the time of the analysis. The study will continue to further assess overall survival.

FDA Approves Expanded Use of J&J’s Rybrevant

J&J announced that the FDA has granted approval for the expanded use of Rybrevant (amivantamab) for advanced NSCLC based on data from the MARIPOSA-2 study. The approval is for Rybrevant in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). In the EU, Rybrevant was approved for a similar use as a combination therapy in August.

At present, Rybrevant is approved in several countries as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. This year Rybrevant has already gained approval in the United States for two new indications in combination use. In August, Rybrevant was approved in combination with Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations. It was approved, in combination with carboplatin and pemetrexed, for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations in March.

The NYSE ARCA Pharmaceutical Index declined 0.3% in the last five trading sessions.