Product Approvals and Launches

Subcutaneous amivantamab joins a growing list of drugs receiving complete response letters due to manufacturing facility issues.

The FDA has approved cosibelimab-ipdl for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.

Martin Dietrich, MD, PhD, discusses how the FDA-approved combination therapy is transforming care for resectable early-stage non–small cell lung cancer (NSCLC).

The accelerated approval was based on the results of the eNRGy trial of 64 patients with NRG1-positive non–small cell lung cancer and 30 patients with NRG1-positive pancreatic adenocarcinoma.

The approval of Yesintek (ustekinumab-kfce), the sixth biosimilar to reference Stelara, will be used to treat patients with various immunology conditions, including psoriatic arthritis and inflammatory bowel disease.

With ponatinib (Iclusig) receiving an accelerated approval from the FDA earlier this year for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), updated guidelines could be on the horizon.

The FDA approval marks the first oral solution indicated for patients with different forms of leukemia.

On November 20, the FDA approved bimekizumab (Bimzelx; UCB Pharma) for use in patients with moderate to severe hidradenitis suppurativa.

Currently, chemotherapy remains a common treatment for biliary tract cancers, which have a limited survival rate.

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.

The latest therapy approved to treat chronic graft-versus-host disease (GVHD) has a new target different than the other approved therapies. Daniel Wolff, MD, also discusses future research on axatilimab to treat chronic GVHD earlier.

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.