PDR Drug Update - September 2025

Innovative Lung Cancer Treatment Approved, Added to Key Guidelines

For the first time, a significant group of lung cancer patients with previously unmet treatment needs has an oral targeted therapy option. The newly approved kinase inhibitor has the potential to offer improved outcomes for these patients, providing effective, chemotherapy-free medication that inhibits tumor cell growth in a hard-to-treat population.

The medication is Hernexeos (zongertinib), which received accelerated approval through the FDA as treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (HER2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. Mutations characterized by abnormal tyrosine kinase activity typically demonstrate uncontrolled cell proliferation. Zongertinib selectively targets the problematic kinases at their binding site, which blocks continued activity, helping prevent the growth and spread of cancerous tumors.

Zongertinib is valuable as an additional option for patients with HER2-mutant NSCLC since few treatments exist, and other current therapies have side effects related to their interactions with targets other than HER2. While clinical trials have demonstrated a beneficial efficacy and safety profile, its prescribing information does include warnings and precautions for hepatotoxicity, left ventricular dysfunction, interstitial lung disease or pneumonitis, and embryofetal toxicity. Since it received approval through an accelerated program that assessed early results, extension of the approval depends on continued studies and determination of its long-term clinical performance.

Shortly after zongertinib was approved, the NCCN Guidelines for NSCLC incorporated new recommendations, listing zongertinib as a preferred therapy for advanced HER2-mutant NSCLC after progression on first-line systemic therapy. The guidelines also state that the therapy can be considered after a patient who has not previously been treated with zongertinib (a zongertinib-naïve patient) progresses on second-line therapy. The inclusion of zongertinib as a preferred therapy may aid healthcare providers in prescribing the medication with confidence. Providers can help improve health outcomes by keeping current on relevant guidelines. A useful tool to aid in this is the newly launched digital format of the NCCN Clinical Practice Guidelines in Oncology, dubbed the NCCN Guidelines Navigator. At present, the new delivery format is available for NSCLC (Version 8.2025, which includes zongertinib recommendations) as well as for bladder, colon, prostate, rectal, and head and neck cancers, and uterine neoplasms.

Advancements exploring the treatment potential of zongertinib as targeted therapy for NSCLC and other cancers characterized by EGFR mutations reinforce the benefit of identifying patients who are candidates for targeted therapy. According to the National Cancer Institute, NSCLC incidence has fallen in the US in recent years, and the institute attributes the improvement to recent advances in treatment. As genetic testing for EGFR mutations and other gene targets increases, and as guidelines and further approvals are achieved after continued research and understanding of long-term results, exciting advances in related targeted therapy will continue. Stay informed about emergent drug information by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Brinsupri

The FDA has approved Brinsupri (brensocatib) tablets, an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children aged 12 years and older. Learn more about Brinsupri

Dawnzera

The FDA has approved Dawnzera (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Dawnzera is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein. Learn more about Dawnzera

Hernexeos

The FDA has granted accelerated approval to Hernexeos (zongertinib), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. Learn more about Hernexeos

Modeyso

The FDA has granted accelerated approval to Modeyso (dordaviprone), a protease activator, for adult and pediatric patients aged 1 year and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Learn more about Modeyso

Papzimeos

The FDA has approved Papzimeos (zampogna imadenovec-drba), a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with recurrent respiratory papillomatosis. Learn more about Papzimeos

Tonmya

The FDA has approved Tonmya (cyclobenzaprine HCl) sublingual tablets for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual formulation that is designed for rapid absorption into the bloodstream. Learn more about Tonmya

Vizz

The FDA has approved Vizz (aceclidine) ophthalmic solution 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Learn more about Vizz

FDA New Indications

Ajovy

The FDA has approved an expanded indication for Ajovy (fremanezumab-vfrm) for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45kg or more. Learn more about Ajovy

Alhemo

The FDA has approved an expanded indication for Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B (HA/HB) without inhibitors, expanding on the December 2024 approval for HA/HB with inhibitors. Learn more about Alhemo

Empaveli

The FDA has approved Empaveli (pegcetacoplan) as the first treatment for C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis in patients aged 12 years and older, to reduce proteinuria. Learn more about Empaveli

Phyrago

The FDA has approved a supplemental new drug application for Phyrago (dasatinib) tablets to include treatment of pediatric patients aged 1 year and older with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase and newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. Learn more about Phyrago

Repatha

The FDA has approved the use of Repatha (evolocumab) to include adults at increased risk for major adverse cardiovascular events due to uncontrolled low-density lipoprotein cholesterol. The update removes a prior requirement for a patient to have been diagnosed with cardiovascular disease. Learn more about Repatha

Wegovy

The FDA has approved a new indication for Wegovy (semaglutide) injection 2.4mg to treat adults with metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis, but not with cirrhosis of the liver, in conjunction with a reduced-calorie diet and increased physical activity. Learn more about Wegovy

FDA Labeling Changes

Leqvio

The FDA has approved a label update for Leqvio (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia. Learn more about Leqvio

Skysona

The FDA has approved labeling changes for increased risk of hematologic malignancy following treatment with Skysona (elivaldogene autotemcel). Learn more about Skysona

FDA Recalls

B. Braun Lactated Ringer’s Injection

B. Braun Medical Inc. is voluntarily recalling two lots of lactated Ringer’s injection USP 1000mL and 0.9% sodium chloride injection USP 1000mL to the hospital level due to the presence of particulate matter inside the container. Learn more about the B. Braun lactated Ringer’s injection recall

DermaRite Products

DermaRite Industries is voluntarily recalling individual lots of products due to microbial contamination identified as Burkholderia cepacia. Products include certain lots of DermaKleen, Dermasarra, Kleenfoam, and Perigiene. Learn more about the DermaRite products recall

September 2025