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Monthly News Roundup - April 2021

GSK’s Checkpoint Inhibitor Jemperli Gains Approval for Endometrial Cancer

The FDA has given accelerated approval to GSK’s Jemperli (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody used to treat adults with mismatch repair-deficient (dMMR) endometrial cancer that has returned or cannot be removed by surgery. These patients have also received a prior platinum-containing regimen. Jemperli works by binding to the PD-1 receptor and blocking interaction with the ligands PD-L1 and PD-L2. An FDA-approved test determines if the cancer is dMMR.

  • Jemperli is given as an intravenous infusion once every 3 weeks for 4 doses, then once every 6 weeks.
  • Approval was based on the ongoing Phase 1 GARNET trial of 71 evaluable patients that demonstrated an overall response rate of 42.3%, with a complete response of 12.7% and a 29.6% partial response rate. Of those that responded, 93.3% demonstrated a duration of response (DOR) of 6 months or more. After 14.1 months, the median DOR was not reached.
  • The most common side effects in at least 20% of patients included fatigue or weakness, nausea, diarrhea, low red blood cells to carry oxygen (anemia), and constipation. 

Zynlonta Cleared for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

In April, the FDA granted accelerated approval to Zynlonta (loncastuximab tesirine-lpyl) from ADC Therapeutics. Zynlonta is used for the treatment of adults with certain types of large B-cell lymphoma that has returned (relapsed) or that did not respond to previous treatment (refractory). These patients have already received 2 or more previous cancer treatments.

  • Zynlonta is given as an intravenous infusion by a healthcare provider, usually every 3 weeks.
  • Approval was based on the pivotal Phase 2 LOTIS-2 study of 145 patients including patients who were transplant eligible and ineligible, previously had received a stem cell transplant, or who had received CAR-T cell therapy.
  • Results demonstrated an overall response rate of 48.3%, with a complete response of 24.1%. The median duration of response for the 70 responders was 10.3 months.
  • Side effects in at least 20% of patients included low blood cells  (platelets, red or white blood cells), high blood sugar, elevated liver enzymes, tiredness, low albumin, rash, swelling due to fluid retention (edema), nausea and muscle and bone pain.

FDA OKs Nextstellis Birth Control Pill with Plant-Based Estrogen

Nextstellis tablets, now approved from Mayne Pharma, contain 3 mg drospirenone and 14.2 mg estetrol (E4) taken once a day for the prevention of pregnancy. Nextstellis is the first contraceptive pill containing estetrol, a naturally occurring estrogen produced from a plant source. Most women in the US use birth control pills that contain ethinyl estradiol, a synthetic estrogen that binds widely to all estrogen receptors in the body.

  • The manufacturer states that Nextstellis has more selective activity in tissues to support contraceptive efficacy, cycle control and other beneficial effects of estrogen.
  • In studies in 3,725 women, Nextstellis was effective at pregnancy prevention and demonstrated favorable cycle control, bleeding control, safety, and tolerability. Nextstellis may be less effective in females with a BMI ≥ 30 kg/m2, and may become less effective as BMI increases. Safety and effectiveness in women with BMI ≥ 35 kg/m2 is not known.
  • Common side effect were irregular bleeding, mood changes, headache, breast symptoms, painful periods, acne, weight gain and lower sex drive.
  • The company expects to launch Nextstellis in June 2021.

Non-Stimulant Qelbree Cleared for the Treatment of ADHD in Children

Qelbree (viloxazine extended-release capsules) from Supernus Pharmaceuticals is now approved for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. Qelbree is also being studied in adults with ADHD.

  • Viloxazine is classified as a selective norepinephrine reuptake inhibitor (SNRI) and is given as an extended-release capsule once a day.
  • The capsules may be swallowed whole or opened and the contents sprinkled onto applesauce. Qelbree comes as a 100 mg, 20 mg or 400 mg capsule. It is not a controlled substance.
  • Approval was supported by data from Phase III randomized, placebo-controlled studies of over 1,000 children 6 to 17 years of age. Doses studied were 100 mg, 200 mg, or 400 mg per day, with treatment duration of  6 to 8 weeks. The primary efficacy measure, the change in the ADHD-RS-5 Total Score from baseline, was met statistically for all doses. 
    The most common side effects (≥5%) were sleepiness, decreased appetite, fatigue, nausea, vomiting, difficulty sleeping and irritability. Qelbree may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed. 

First-in-Class Trodelvy Approved to Treat Metastatic Urothelial Cancer

This April, Gilead’s Trodelvy (sacituzumab govitecan-hziy) received accelerated approval for the treatment of adults with locally advanced or metastatic urothelial (bladder) cancer who have previously received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. In April 2020, Trodelvy was first approved to treat adults with metastatic triple-negative breast cancer (mTNBC).

  • Urothelial cancer is the most common type of bladder cancer and occurs when the urothelial cells that line the inside of the bladder grow uncontrollably.
  • Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor.
  • Accelerated approval for Trodelvy was based on the Phase 2, single-arm TROPHY study. Of the 112 patients who were evaluable for efficacy, 27.7% responded to treatment, with 5.4% showing a complete response and 22.3% having a partial response. The median duration of response was 7.2 months.
  • Trodelvy carries a Boxed Warning for severe neutropenia and severe diarrhea. Common side effects include diarrhea (72%), anemia (71%), fatigue (68%), neutropenia (67%), nausea (66%) and vomiting (34%), hair loss (49%), and decreased appetite (41%) among others.

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