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Monthly News Roundup - June 2020

Genentech’s Phesgo Approved Four Months Early for At-Home Breast Cancer Treatment


The U.S. Food and Drug Administration (FDA) has approved Phesgo, a new option for at-home breast cancer treatment. Phesgo is a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, for the treatment of early and metastatic HER2-positive breast cancer.

  • Phesgo is initially used in combination with chemotherapy, then can be given at home by a healthcare provider after chemotherapy is done. Phesgo is administered under the skin (subcutaneously) in just 5 to 8 minutes compared to 60 to 150 minutes with intravenous (IV) administration.
  • In studies, Phesgo had comparable effectiveness and safety as IV pertuzumab and IV trastuzumab, except for reactions due to the subcutaneous route of administration.
  • Phesgo includes a Boxed Warning about the risk of potential heart failure, harm to an unborn baby, and lung toxicity. The most common side effects were alopecia (hair loss), nausea, diarrhea, anemia (reduced number of red blood cells) and asthenia (lack of energy).

FDA Approves Fintepla for Childhood Seizures Associated with Dravet Syndrome

Dravet syndrome is a rare childhood epilepsy marked by frequent debilitating seizures, developmental impairments, and an increased risk of sudden death.

  • This month the FDA approved Fintepla (fenfluramine) oral solution to treat seizures associated with Dravet syndrome in patients 2 years of age and older.
  • In two pivotal Phase 3 trials, the reduction in monthly convulsive seizure frequency was statistically significantly greater for all dose groups of Fintepla (when added to existing treatments) compared to an inactive placebo.
  • Fintepla contains a Boxed Warning for valvular heart disease and pulmonary arterial hypertension and is available only through a restricted REMS program.
  • Fintepla, from Zogenix, is an amphetamine derivative and a C-IV controlled substance. It is expected to be available via specialty pharmacy channels in July.

Gimoti Nasal Spray is Cleared for Diabetic Gastroparesis in Adults

This month, the FDA approved Evoke Pharma’s Gimoti (metoclopramide) nasal spray, a dopamine-2 (D2) antagonist and the first nasal spray for adults with acute and recurrent diabetic gastroparesis.

  • In diabetic gastroparesis, delayed emptying of the stomach can cause nausea, stomach pain, bloating, early satiety (feeling full) as well as vomiting and can interfere with absorption of oral medications.
  • The nasal spray formulation allows the drug to enter the bloodstream directly and may provide more predictable delivery. The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily) for 2 to 8 weeks, depending on symptomatic response.
  • The effectiveness of Gimoti was established based on studies of oral metoclopramide in diabetic gastroparesis. Gimoti contains a Boxed Warning for tardive dyskinesia and the most common side effects (≥5%) are: dysgeusia (altered taste), headache, and fatigue.

Zepzelca Receives Accelerated Approval for Metastatic Small Cell Lung Cancer

PharmaMar and Jazz Pharmaceuticals announce accelerated approval of Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression, after platinum-based chemotherapy. Zepzelca is an alkylating drug that interrupts the cell cycle causing cell death.

  • Approval was based on a Phase 2, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with relapsed small cell lung cancer (SCLC). Zepzelca demonstrated an overall response rate (ORR) of 35% and a median duration of response (DoR) of 5.3 months as assessed by investigators. Accelerated approval is conditional based upon further confirmatory trials.
  • Zepzelca is given by an intravenous (IV) infusion over 60 minutes and is repeated every 21 days until disease progression or unacceptable toxicity. Zepzelca should be commercially available in early July.
  • Common side effects include myelosuppression (decreased blood cell production from bone marrow), fatigue, increased creatinine (a measure of kidney function), increased glucose (blood sugar), nausea or a decreased appetite.

FDA Approves Lyumjev, a Lower-Cost Insulin for Type 1 and Type 2 Diabetes 

In June, the FDA cleared Eli Lilly’s Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), a rapid-acting insulin indicated to improve glycemic control in adults with type 1 diabetes and type 2 diabetes. Lyumjev controls high blood sugar levels after meals, similar to how natural insulin works in those without diabetes.

  • In Phase 3 comparative studies of Lyumjev and Humalog (insulin lispro injection, 100 units/mL), Lyumjev demonstrated noninferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime.
  • Lyumjev and Humalog also had similar safety and tolerability profiles.
  • Lyumjev will be included in the Lilly Insulin Value Program, allowing anyone with commercial insurance and those without insurance to fill their monthly prescription for $35. This savings option can be obtained by calling the Lilly Diabetes Solution Center at (833) 808-1234.

FDA Approves Uplizna for Neuromyelitis Optica Spectrum Disorder (NMOSD)

In June, the FDA approved Viela Bio’s Uplinza (inebilizumab-cdon), a CD19-directed cytolytic antibody, for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive.

  • NMOSD is a rare autoimmune inflammatory nerve disease that affects about 10,000 people in the US. Patients may experience irreversible blindness, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory (breathing) failure. Roughly 80% of all patients with NMOSD test positive for anti-AQP4 antibodies.
  • In the pivotal N-MOmentum clinical study with Uplinza, 89% of patients in the anti-AQP4 antibody positive group remained relapse-free during the six-month period post-treatment compared to 58% of the patients taking placebo. Hospitalizations were also reduced. Uplinza is given as a twice-a-year maintenance regimen following initial doses.
  • The most common side effects included urinary tract infection (20%), common cold (13%), infusion reaction (12%), joint pain (11%), and headache (10%). 

 

 

 

 

Posted: June 2020