New Dosage Form for Ocrevus  

On Sept. 13, 2024, the U.S. Food and Drug Administration (FDA) approved Ocrevus Zunovo^™ (ocrelizumab & hyaluronidase-ocqs – Genentech), a new subcutaneous (SC) formulation for the treatment of adults who have relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus^® (ocrelizumab – Genentech) injection for intravenous (IV) use is a monoclonal antibody that disrupts the activity of CD20-positive B cells, which play a role in damaging nerve cells (axons) and their coverings (myelin sheaths). Ocrevus was the first drug approved for treating PPMS. Like Ocrevus, Ocrevus Zunovo is administered every six months by a healthcare provider; however, it is administered SC in about 10 minutes while the IV infusion is administered over two or more hours. Ocrevus Zunovo contains Enhanze^® drug delivery technology that allows the drug to be rapidly absorbed into the bloodstream. Ocrevus Zunovo showed safety and efficacy consistent with the IV formulation in people with RMS and PPMS and did not show any clinically significant differences in levels in the blood when administered SC. Launch date and pricing information aren’t available at this time. Prescribing information may be found here.

Kisqali Gets a New Indication

Novartis’ Kisqali^® (ribociclib) obtained a new FDA approval on Sept. 17, 2024. Originally indicated as a first-line treatment for postmenopausal women who have metastatic or advanced hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) breast cancer, it is now also approved for the adjuvant treatment of people with HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease.  Kisqali selectively inhibits cyclin-dependent kinase (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spread of cancer cells. It will be used in combination with fulvestrant or an aromatase inhibitor, such as anastrozole, exemestane or letrozole. In a population that faces a high risk of cancer recurrence, especially in the first years, Kisqali reduced the risk of cancer recurrence by 25% versus standard therapy alone. The recommended dose in EBC is on four-week cycles, with 400mg (two tablets) of Kisqali taken once daily every day for 21 days, then stopped for the next seven days for three years. The aromatase inhibitor is taken continually without a break. Gaining this indication is expected to approximately double the eligible population for Kisqali. Here is Kisqali’s updated prescribing information.

Fasenra Approved for Eosinophilic Granulomatosis with Polyangiitis

The FDA approved Fasenra^® (benralizumab – AstraZeneca) on Sept. 18, 2024, for eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, autoimmune disease that inflames small blood vessels and results in damage to multiple organs. There are limited treatment options, including high-dose oral corticosteroids (OCS) and Nucala^® (mepolizumab – GSK), and without treatment, the disease may be fatal. The Phase III trial was the first head-to-head comparison of biologics and showed that Fasenra 30mg SC injection every four weeks was non-inferior to three Nucala 100mg SC injections every four weeks in patients with EPGA and showed that 41% of Fasenra-treated patients were able to fully taper off OCS, compared to 26% of those taking Nucala. Fasenra is a SC interleukin-5 (IL-5) blocker on eosinophils, white blood cells that contribute to increased sensitivity of the airways among affected patients. It is also indicated for severe asthma and asthma with an eosinophilic phenotype. Nucala is also an IL-5 blocker. Updated prescribing information for Fasenra can be found here.

Another Indication for Keytruda

On Sept. 18, 2024, the FDA approved Keytruda^® (pembrolizumab – Merck) for the first-line treatment of adults who have unresectable advanced or metastatic pleural mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy. MPM develops in the lining of the lungs, can progress rapidly, and has a 12% five-year survival rate. Approval was based on a Phase II/III study in which individuals treated with the approved combination compared to chemotherapy alone reduced the risk of death by 21%, a significant improvement in overall survival. There were also improvements in progression-free survival and a higher overall response rate in the Keytruda-treated group, both statistically significant. Keytruda has numerous other FDA approvals with and without other cancer drugs for treating various types of endometrial cancer, non-small cell lung cancer (NSCLC), some kidney cancers, some esophageal, stomach and head and neck cancers, as well as Merkel cell carcinoma, multiple myeloma, and non-Hodgkin lymphoma. It also has indications for pediatric and adult patients whose cancers have specific genetic characteristics (biomarkers) rather than developing from a particular body tissue. For most of its indications, including the newly extended one, the recommended dose is 200mg once every three weeks or 400mg once every six weeks administered as a 30-minute IV infusion. Here is its current prescribing information.

New Indication for Rybrevant

On Sept. 20, 2024, Johnson and Johnson Innovative Medicine was granted a new indication for Rybrevant^® (amivantamab-vmjw) to be used in adults who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, in combination with carboplatin and pemetrexed, after the disease has progressed or after treatment with a EGFR tyrosine kinase inhibitor (TKI). Rybrevant also has indications to be used as monotherapy, to treat patients who have NSCLC that has EGFR exon 20 insertion mutations, as diagnosed with a companion diagnostic test, and that has returned or become resistant to prior or current platinum-based chemotherapy (chemo). Rybrevant also has an indication to include initial treatment in combination with chemo that includes carboplatin and pemetrexed for EGRF-mutated NSCLC. A third indication is for combination with Lazcluze^™ (lazertinib) for the first-line treatment of adult patients who have locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. Rybrevant is a fully-human bispecific antibody that targets EGFR and mesenchymal-epithelial transition factor (MET). It is given by IV infusions once a week for four weeks, then every two weeks, with doses determined by body weight. Approval was based on the MARIPOSA-2 study that found patients treated with Rybrevant and the combination with carboplatin and pemetrexed showed a reduced risk of disease progression or death by 52% compared to chemotherapy alone. It also showed improvements in progression-free survival (PFS) and overall response rates (ORR). For full prescribing information, see here.

Ocaliva Advisory Committee Summary Document Available

The Emerging Therapeutics department has summarized a recent FDA Gastrointestinal Drugs Advisory Committee Meeting (AdComm) meeting that discussed the supplemental new drug application (sNDA) for Ocaliva^® (obeticholic acid – Intercept), completing accelerated approval postmarking requirements needed for full approval. The majority of the committee members voted that the available data doesn’t confirm that Ocaliva improves clinical outcomes in patients with primary biliary cholangitis. The FDA is not expected to grant full approval by its Prescription Drug User Fee Act (PDUFA) date of Oct. 15, 2024. The summary document is attached

Updated DrugWatch Document Available The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is attached.