March 2023

PDR Drug Update 

Increased Precision in Ovarian Cancer Therapy
One of the most frequent causes of death from cancer in females is epithelial cancer of the ovary. There is an urgent need to find better treatments, especially to aid those with advanced disease that is resistant to current standard of care options. Progress is underway as new antibody-drug conjugate therapy is emerging as an effective approach for helping certain patients with ovarian cancer.

While there has been a noted decline in ovarian cancer diagnoses and death since the nineties, it is still estimated that nearly 20,000 new cases will be diagnosed this year, and over 13,000 patients will not survive their illness. The prognosis for ovarian cancer patients is typically poor, as many cases involve high-grade serous carcinoma that is often diagnosed at a later stage of disease. In order to improve survival, cytoreductive surgery is recommended, which will usually be followed by platinum-based chemotherapy (commonly carboplatin or paclitaxel, often with the addition of bevacizumab). An unfortunate majority of patients experience ovarian cancer that returns after these treatments. Recurrence of ovarian cancer within six months is considered platinum-resistant, placing patients in an even more difficult-to-treat disease state as therapeutic options are very limited with high toxicity.

The FDA has granted fast-track approval to a first-in-class agent that is showing the potential to renovate the standard of care for platinum-resistant patients. The approval was for Elahere (mirvetuximab soravtansine-gynx), an injectable antibody-drug conjugate that is able to target folate receptor alpha (FRα), a protein that epithelial tumors tend to overexpress. The ability of mirvetuximab soravtansine to selectively target tumor tissue while leaving normal tissues unaffected is a valuable and much-desired quality in ovarian cancer treatment. The antibody portion of the conjugate binds to FRα, granting the drug entry to the cell it binds to. After the drug is inside the cell, its chemotherapy portion, DM4, activates, leading to cancer cell death. This precise targeting is the type of action researchers have been seeking in order to push past current ovarian cancer treatment limitations. The prior response rates for standard care measures were under 10%, but mirvetuximab soravtansine has demonstrated rates triple those, which is a strong and promising improvement.

The indication for Elahere is treatment of adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The prescribing information for the new approval also includes a boxed warning for ocular toxicity. This includes instances of visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. In order to identify patients who are eligible for treatment, an immunohistochemical diagnosis for detection of the folate receptor biomarker is necessary. Along with the Elahere approval, the FDA also endorsed the Ventana FOLR1 (FOLR-2.1) RxDx Assay, a first-ever companion diagnostic for the FOLR1 biomarker in patients with ovarian cancer.

Continued research and discovery are underway to develop deeper knowledge that will further define the role mirvetuximab soravtansine will play as a potential standard of care in cancer treatment. Stay informed about emergent drug information, including treatment options for gynecological cancers, by updating or registering your profile to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, mobilePDR, available for free from your favorite app stores.

FDA New Approvals

Altuviiio

The FDA has approved Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl), previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy. Altuviiio is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management for adults and children with hemophilia A. Learn more about Altuviiio

Atorvaliq

The FDA has approved Atorvaliq (atorvastatin calcium) oral suspension. The approval provides for the use of Atorvaliq to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD; MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD; non-fatal MI, and of fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD; as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia; as an adjunct to other LDL-C lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia; and as an adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia or hypertriglyceridemia. Learn more about Atorvaliq

Combogesic

The FDA has approved Combogesic (acetaminophen/ibuprofen) tablets for oral use. Combogesic is a combination of acetaminophen and ibuprofen, a nonsteroidal anti-inflammatory drug, and is indicated in adults for the short-term management of mild to moderate acute pain. Learn more about Combogesic

Daybue

The FDA has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients aged two years and older. Daybue is the first and only drug approved for the treatment of Rett syndrome. Learn more about Daybue

Filspari

The FDA has approved Filspari (sparsentan) to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression, generally a urine protein-to-creatinine ratio ≥1.5 g/g. Learn more about Filspari

Lamzede

The FDA has approved Lamzede (velmanase alfa), the first enzyme replacement therapy approved in the US for the treatment of the non-central nervous system manifestations of alpha-mannosidosis, a rare genetic condition characterized by the lack of the alpha-mannosidase enzyme in the body. Learn more about Lamzede

Maxigesic Rapid

The FDA has approved a rapid-release tablet form of Maxigesic (acetaminophen/Ibuprofen) for the management of mild to moderate acute pain in the US. Learn more about Maxigesic

Prevduo

The FDA has approved Prevduo (glycopyrrolate/neostigmine methylsulfate) injection, for intravenous use. Prevduo is a fixed dose combination of a cholinesterase inhibitor and antimuscarinic agent, is indicated in patients aged two years and above for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery, while decreasing the peripheral muscarinic effects (eg, bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration. Learn more about Prevduo

Skyclarys

The FDA has approved Skyclarys (omaveloxolone) for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. With this approval, the FDA granted a rare pediatric disease priority review voucher. Learn more about Skyclarys

Syfovre

The FDA has approved Syfovre (pegcetacoplan) injection for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. Syfovre is the first and only FDA-approved treatment for GA. Learn more about Syfovre

Zavzpret

The FDA has approved Zavzpret (zavegepant), the first and only calcitonin gene-related peptide receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. Learn more about Zavzpret

 

FDA New Formulations

Austedo XR

The FDA has approved Austedo XR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington's disease. Austedo XR is an additional formulation of the currently marketed twice-daily Austedo. Learn more about Austedo XR

Hyrimoz

The FDA has approved Hyrimoz (adalimumab-adaz) high-concentration formulation (HCF). The adalimumab citrate-free HCF (100mg/mL) is approved to treat seven indications covered by the reference medicine, Humira (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Learn more about Hyrimoz

FDA New Indications

Cibinqo

The FDA has approved Cibinqo (abrocitinib) with an expanded indication to include adolescents (12 to <18 years) with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Cibinqo was previously approved only for the treatment of adults 18 years and older. Learn more about Cibinqo

Eylea

The FDA has approved Eylea (aflibercept) injection to treat preterm infants with retinopathy of prematurity. Following this first pediatric approval, Eylea is now indicated to treat five retinal conditions caused by ocular angiogenesis. Learn more about Eylea

Illuccix

The FDA has approved an expanded indication for Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated. The label expansion means Illuccix is now approved in the US to select patients who are candidates for the only FDA-approved PSMA-directed radioligand therapy (Pluvicto [lutetium Lu 177 vipivotide tetraxetan]). To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent. Learn more about Illuccix

Jemperli

The FDA has approved Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. Learn more about Jemperli

Kevzara

The FDA has approved Kevzara (sarilumab) for the treatment of polymyalgia rheumatica, an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. Learn more about Kevzara

Lutrate Depot

The FDA has approved the gonadotropin-releasing hormone agonist Lutrate Depot (leuprolide acetate for depot suspension) for treatment of advanced prostate cancer. Learn more about Lutrate Depot

Synjardy and Synjardy XR

The FDA has approved Synjardy (empagliflozin and metformin hydrochloride) and Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets to include the indication for empagliflozin to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. Learn more about Synjardy and Synjardy XR

Takhzyro

The FDA has approved the expanded use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged 2 to <12 years. Prior to the approval, the only approved routine prophylaxis treatment options for children aged 6 to <12 required dosing every three to four days, and children with HAE aged 2 to <6 years had no approved prophylaxis treatment, making Takhzyro the first prophylaxis treatment for this age group. Learn more about Takhzyro

Trodelvy

The FDA has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. Learn more about Trodelvy

Verzenio

The FDA has approved an expanded indication for Verzenio (abemaciclib), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence. High-risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5cm or Grade 3). This expanded adjuvant indication removes the Ki-67 score requirement for patient selection. Learn more about Verzenio

 

FDA New Combinations

Tafinlar + Mekinist

The FDA has approved Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of pediatric patients aged one year and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy. The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients aged as young as one year. These approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG. Learn more about Tafinlar + Mekinist

 

FDA Recalls

Apotex Brimonidine Tartrate Ophthalmic Solution

Apotex Corp., with the knowledge of the FDA, is initiating a voluntary recall at the consumer level for six lots of brimonidine tartrate ophthalmic solution, 0.15%. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the caps of brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and, if so, the possibility of adverse events. Learn more about the Apotex brimonidine tartrate ophthalmic solution recall

Global Pharma Healthcare Artificial Eye Ointment

Global Pharma Healthcare is voluntarily recalling batch No. H29 of artificial eye ointment, distributed by Delsam Pharma, to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised. Learn more about the Global Pharma Healthcare artificial eye ointment recall

Global Pharma Healthcare Artificial Tears Lubricant Eye Drops

Global Pharma Healthcare is voluntarily recalling all lots within expiry of their artificial tears lubricant eye drops, distributed by EzriCare and Delsam Pharma, to the consumer level, due to possible contamination. The CDC alerted the FDA to an investigation of a multi-state cluster of infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. As of the recall announcement date, there were 55 reports of adverse events, including eye infections, permanent loss of vision, and a death with a bloodstream infection. Learn more about the Global Pharma Healthcare artificial tears lubricant eye drops recall

Nanomaterials Discovery Corporation Hand Sanitizer

Nanomaterials Discovery Corporation is voluntarily recalling all lots of its alcohol antiseptic 80% alcohol solution branded as "Snowy Range Blue" in 4 fl. oz. spray dispenser packaging, to the consumer level. Certain batches of the company's hand sanitizer product may exceed FDA limits for methanol. Learn more about the Nanomaterials Discovery Corporation hand sanitizer recall

Pharmedica MSM Drops

Pharmedica is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility. Learn more about the Pharmedica MSM drops recall

Volt Candy Male Enhancement Capsules

Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000mg capsule, to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil and tadalafil. Learn more about the Volt Candy male enhancement capsules recall

FDA Alerts

Contaminated Artificial Tears and Artificial Eye Ointment

The FDA warned consumers and healthcare practitioners not to purchase and to immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears or Artificial Eye Ointment due to potential bacterial contamination. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile. The FDA subsequently recommended that Global Pharma recall Delsam Pharma's Artificial Eye Ointment, and the firm agreed to initiate a recall. Learn more about the contaminated artificial tears and artificial eye ointment warning

Unapproved Potassium Phosphates Drug Product

The FDA is warning healthcare professionals and pharmacies to avoid using Hospira's unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this product is unsafe for this population. Learn more about the unapproved potassium phosphates drug product warning

Labeling Updates

  • Key
  • Boxed Warning
  • Other Warnings*

    *Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications

  • Updates to Indications/Dosage
  • Other Updates†

    †Other labeling changes; added to PDR database

No Liletta SHI boxed warning Liletta SHI has Other Warnings No Liletta SHI Indications/Dosage Updates Liletta SHI has Other Updates Liletta SHI (levonorgestrel)