Product Approvals and Launches

This approval is the fifth overall for bimekizumab (Bimzelx; UCB Pharma) in the US, and they all have come in the last 13 months.

The FDA approved the FoundationOne Liquid CDx to identify patients with metastatic non–small cell lung cancer (mNSCLC) with MET exon 14 skipping alterations who may be eligible for tepotinib (Tepmetko; EMD Serono).

Revumenib has been approved for relapsed or refractory acute leukemia with KMT2A translocation in patients aged 1 year and older.

The FDA has granted approval to Azurity Pharmaceuticals' nilotinib tablets (Danziten), a novel version of the tyrosine kinase inhibitor for chronic myeloid leukemia that can be taken without mealtime restrictions.

The approval marks the first time gene therapy will be available to treat patients with aromatic I-amino acid decarboxylase (AADC) deficiency.

The chimeric antigen receptor T-cell therapy obecabtagene autoleucel received approval to treat patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia.

Principal treatment-related toxicities that come from amivantamab administration include skin-related reactions, higher risk of venous thrombolism, and infusion-related reactions.

The FDA has approved oxycodone hydrochloride (RoxyBond) for the management of severe pain when other treatments have proved inadequate.

Abrysvo is the first and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50 years.

Optune Lua creates tumor-treating fields to disrupt cancer cell division, and it is used in conjunction with PD-1/PD-L1 inhibitors or docetaxel to treat metastatic non–small cell lung cancer (NSCLC) that has not responded to platinum-based treatment.

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

Patients with endocrine-resistant, HER2-negative, locally advanced or metastatic breast cancer can use the treatment after recurrence or completing adjuvant endocrine therapy.

The approval came days before the FDA’s expected deadline and makes this the only PD-1 inhibitor approved for resectable non–small cell lung cancer (NSCLC) in the neoadjuvant and adjuvant settings.

Surbhi Sidana, MD, MBBS, shares how the addition of an anti-CD38 antibody to the VRd regimen significantly improves progression-free survival for patients with transplant-ineligible multiple myeloma.

On September 20, the FDA approved isatuximab plus bortezomib, lenalidomide, and dexamethasone in the first line for patients who have multiple myeloma and are ineligible for transplant.

In less than a month, from August 20 to September 19, amivantamab (Ami; Rybrevant, Johnson & Johnson) received 2 approvals from the FDA for use in non–small cell lung cancer (NSCLC).

On September 19, the FDA handed down its third amivantamab (Rybrevant; Johnson & Johnson) approval for 2024 in non–small cell lung cancer (NSCLC), giving the third-generation tyrosine kinase inhibitor its fourth approval overall.

Formally known as KarXT, xanomeline-trospium chloride (Cobenfy) receives approval from the FDA for the treatment of schizophrenia in adults.

The approval means an additional indication for osimertinib (Tagrisso; AstraZeneca) for adult patients who have unresectable stage III non–small cell lung cancer (NSCLC) with EGFR mutation.

The FDA has approved FluMist (AstraZeneca) for self-administration by adults up to age 49 years or for caregiver administration for children aged 2 to 17 years, making it the first self-administered flu vaccine option.

Bimekizumab-bkzx (Bimzelx) is now FDA approved for 4 chronic immune-mediated inflammatory diseases: psoriatic arthritis, nonradiographic axial spondyloarthritis (axSpA), ankylosing spondylitis, and moderate to severe plaque psoriasis.

Isatuximab (Sarclisa) with bortezomib, lenalidomide, and dexamethasone (VRd) is now an approved option for adults who cannot receive an autologous stem cell transplant to treat their newly diagnosed multiple myeloma.

The FDA approval of amivantamab-vmjw (Rybrevant) in combination with chemotherapy is the first targeted treatment to cut disease progression risk for EGFR-positive non–small cell lung cancer (NSCLC).

The FDA approved benralizumab (Fasenra) for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

The FDA approved ribociclib (Kisqali) for adjuvant treatment of high-risk, hormone receptor-positive, HER2-negative early breast cancer.

Ocrelizumab and hyaluronidase is now the first and only twice-yearly subcutaneous injection approved for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

Alzheimer disease research is yielding breakthroughs with blood tests and brain scans that can enhance early diagnosis, while new drugs promise to slow the disease and improve patients’ lives.