Indication Expanded for Zulresso
The U.S. Food and Drug Administration (FDA) broadened the indication for Sage Therapeutics‘ Zulresso® (brexanolone) C-IV injection for infusion on June 16, 2022.
Originally limited to patients at least 18 years old, the one-time treatment for postpartum depression (PPD) can now be used for patients who are as young as 15 years old. It is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator that partially stimulates GABAA receptors in the brain. Only available at registered medical facilities, Zulresso is given by trained healthcare providers as an intravenous (IV) infusion over 60 hours at dosage rates that increase to 90mcg/kg/hr and then taper back down.
Due to the risks of extreme sleepiness and abruptly lost or altered consciousness during the infusion, Zulresso has both a boxed warning and a risk evaluation and mitigation strategy (REMS). Patients, who must be enrolled in the REMS before receiving treatment, need continual monitoring during the entire infusion. Another person who is able to assist, if necessary, should be close by while patients are with their babies.
The full antidepressant effects of Zulresso begin within a few days, as compared with the several weeks usually needed for most oral antidepressants to reach their peak effectiveness.
Pediatric Indication for Vaxneuvance
Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine – Merck) was first FDA approved in July 2021 to prevent invasive disease caused by 15 strains (serotypes) of Streptococcus pneumoniae for patients at least 18 years old. On June 17, 2022, its approval was extended to children as young as six weeks old.
Part of routine immunizations for very young children, the first three doses of pneumonia vaccine, which typically begin at two months of age, are repeated at four months and six months. A fourth dose is given when the child is 12 months to 15 months old. For children at least two years old and teens, only one dose is needed. All doses of Vaxneuvance doses are 0.5mL injected intramuscularly (IM). It can be used for individuals who already have had a different pneumonia vaccine as well as for those who previously have not been vaccinated against pneumonia.
In the U.S., Merck currently also markets Prevnar 13®, which vaccinates against 13 of the same strains of bacteria that Vaxneuvance does, as well as Pneumovax® 23, a vaccine for 23 pneumonia serotypes that immunizes patients who are 50 years old or older and patients no less than two years old who are at high risk for pneumonia. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) already has revised their recommendations for childhood pneumonia vaccines to include Vaxneuvance. It received the pediatric indication through the FDA’s Breakthrough Therapy and Priority Review pathways.
New Indication for Tafinlar and Mekinist
Two of Novartis’ targeted oncology drugs, Tafinlar® (dabrafenib) capsules and Mekinist® (trametinib) tablets, were granted Accelerated Approval for an additional FDA indication on June 22, 2022. Further positive results will be needed before full FDA approval.
Both drugs are kinase inhibitors that work in different ways to block abnormal cell growth stimulated by mutations in the BRAF gene. In combination, they now are indicated for patients at least six years old who no longer have other remaining therapy choices for previously treated inoperable or metastatic solid tumors that have BRAF V600E mutations. A diagnostic test must confirm specific mutations before therapy is initiated.
Recommended dosing for patients under the age of 18 years is based on the patient’s body weight. Adults take 150mg (two capsules) of Tafinlar twice a day and 2mg of Mekinist once a day. In a clinical study of Tafinlar and Mekinist’s effectiveness for patients who have many different types of cancer, the response rate was as high as 80%. Patients should be observed for any signs of anemia, new skin cancers, excessive bleeding or blood clots. Left ventricular ejection fraction (LVEF) also should be checked before starting therapy and regularly during treatment. Used together, the drugs also are FDA approved for treating some BRAF-mutated melanoma, non-small cell lung cancer (NSCLC) and thyroid cancers.
Withdrawal of One Indication for Rubraca
Clovis Pharmaceuticals began withdrawing one FDA-approved indication for its poly (ADP-ribose) polymerase (PARP) inhibitor, Rubraca® (rucaparib) tablets, on June 10, 2022.
The decision was due to results from a continuing clinical study of patients whose ovarian cancer, which tested positive for breast cancer (BRCA) mutations, had progressed or become treatment resistant despite two or more previous therapies. More study patients taking Rubraca died, as compared to patients being treated with chemotherapy (chemo). Rubraca was particularly ineffective for patients whose cancer also did not respond to platinum-based chemo. Neither of Rubraca’s other indications – for maintenance after chemo containing a platinum drug has produced at least a partial response for patients who have recurrences of epithelial ovarian, fallopian tube or primary peritoneal cancers; and for previously treated patients who have certain types of BRCA-mutated metastatic, castration-resistant prostate cancer – are not affected by the withdrawal. For updated prescribing information, please look here.