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Monthly News Roundup - November 2023

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Nov 29, 2023.

FDA Approves Lilly’s Zepbound for Chronic Weight Management

In November, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Zepbound (tirzepatide), a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist used for weight loss in adults with obesity (BMI ≥ 30 kg/m²) or who are overweight (BMI ≥ 27 kg/m²) and have weight-related medical conditions like high blood pressure, type 2 diabetes, heart disease or high lipid levels.

• Lilly’s Mounjaro, which also contains tirzepatide, was first approved for blood sugar control in adults with type 2 diabetes in May 2022.
• Zepbound works for weight loss by activating the receptors for the natural incretin hormones GIP and GLP-1. This helps to slow the movement of food through the digestive tract, decreases the appetite, and increases and prolongs the feeling of being full after eating.
• Zepbound is given as a once-weekly subcutaneous (under the skin) injection into the stomach area, thigh, or upper arm using a pre-filled, single-dose pen.
• Approval was based on results from the 72-week, Phase 3 SURMOUNT studies. In SURMOUNT-1, people without type 2 diabetes taking Zepbound 15 mg lost an average of 48 lbs, and those taking 5 mg lost an average 34 lbs. (compared to 7 lbs. on placebo, an inactive treatment). In SURMOUNT-2, people with type 2 diabetes taking Zepbound 15 mg lost an average of 34 lbs. and those on the 10 mg dose lost an average of 30 lbs. compared to 7 lbs. on placebo.
• Stomach side effects are common and may be severe. Zepbound also carries a Boxed Warning for the risk of thyroid C-cell tumors. The most common side effects include nausea, diarrhea, vomiting, constipation, stomach area pain, heartburn, injection site reactions, tiredness, allergic reactions, belching / burping, and hair loss.
• Zepbound is expected to be available in the U.S. by the end of the year in 6 strengths (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg).

FDA Clears First-in-Class Truqap for Advanced Forms of HR+ Breast Cancer

This past month the FDA cleared AstraZeneca’s Truqap (capivasertib) to be used in combination with Faslodex (fulvestrant) for the treatment of adults with hormone receptor (HR)-positive, HER2-negative breast cancer. Eligible patients have locally advanced (inoperable) or metastatic (spread to other parts of the body) cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) and whose disease has progressed on or after endocrine therapy

• Changes in PIK3CA, AKT1 and PTEN genes occur frequently and can affect up to 50% of patients with advanced HR-positive breast cancer. The FDA has also approved a companion diagnostic test.
• Truqap is a first-in-class adenosine triphosphate (ATP)-competitive inhibitor of all 3 AKT isoforms and works by blocking pathways that help the cancer cells survive and grow.
• The recommended dose is 400 mg orally twice daily (with or without food) for 4 days followed by 3 days off each week.
• Approval was based on the CAPItello-291 Phase 3 study with 708 participants and showed that Truqap + Faslodex led to a 50% reduction in the risk of disease progression or death in the PI3K/AKT pathway biomarker-altered population, with a median progression-free survival (PFS) of 7.3 months versus 3.1 months with Faslodex + placebo.
• Warnings and precautions with Truqap include high blood sugar levels (hyperglycemia), diarrhea, skin reactions, and harm to an unborn baby.
• Common side effects include diarrhea, skin reactions, nausea, vomiting, tiredness, mouth sores, and changes in lab test results.

Augtyro Approved in ROS1-Positive Non-Small Cell Lung Cancer

In November, Bristol Myers Squibb announced the approval of Augtyro (repotrectinib) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Augtyro is an oral tyrosine kinase inhibitor (TKI) therapy that targets ROS1 oncogenic fusions.

• ROS1-positive lung cancer is typically aggressive and may spread to the bones and the brain. Patients are selected for treatment based on the presence of ROS1 rearrangements in tumor specimens.
• The recommended dose is 160 mg orally once daily (with or without food) for 14 days, then increased to 160 mg twice daily.
• Approval was based on the TRIDENT-1 open-label, single-arm, Phase 1/2 trial. In 71 TKI-naïve patients, the objective response rate (ORR) was 79% with a median duration of response (mDOR) of 34.1 months. Among 56 patients pretreated with one prior ROS1 TKI and no prior chemotherapy, the ORR was 38% and the mDOR was 14.8 months. The ORR measures the percentage of people with a partial response (tumor size decreased) or complete response (no longer have signs of cancer). Of patients with measurable brain tumors, responses were seen in 7 of 8 TKI-naïve patients and 5 of 12 TKI-pretreated patients.
• Serious side effects include: central nervous system (CNS) effects, and problems with the lungs, liver, muscles, bones, or uric acid levels. Common side effects include dizziness, taste changes, numbness or tingling in arms / legs, constipation, shortness of breath, trouble with balance, tiredness, problems with thinking (forgetfulness, confusion, hallucinations), and muscle weakness.
• Augtyro is expected to be commercially available in mid-December.

FDA Approves Fruzaqla for Previously Treated Metastatic Colorectal Cancer

In November, the FDA approved Takeda’s Fruzaqla (fruquintinib), an oral targeted therapy for adults with previously treated metastatic colorectal cancer (mCRC). Eligible patients have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

• In the U.S. roughly 153,000 new cases of colorectal cancer (CRC) will be diagnosed in 2023. About 70% of patients with CRC will experience metastatic disease.
• Fruzaqla is an inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2 and 3 and works by blocking tumor angiogenesis, the process by which new blood vessels form to feed tumor growth. It is the first agent to target all 3 receptor kinases for patients with previously treated mCRC regardless of biomarker status.
• The recommended dose of Fruzaqla is 5 mg orally once daily, with or without food, for the first 21 days of each 28-day cycle, until disease progression or unacceptable toxicity occurs.
• FDA approval of Fruzaqla is based on data from the Phase 3 FRESCO trials that compared the drug or placebo (pill with no medicine) plus best supportive care in patients with previously treated mCRC. In the FRESCO study, patients in the Fruzaqla group had a median overall survival of 9.3 months versus 6.6 months in the placebo group. In the FRESCO 2 study, median overall survival was 7.4 months in the Fruzaqla group versus 4.8 months in the placebo group. Both FRESCO and FRESCO-2 met their primary and key secondary efficacy endpoints
• Warnings include high blood pressure, bleeding, infections, perforation/fistula in the stomach or intestine, hand-foot skin reactions and liver toxicity, among others. The most common side effects include voice changes or hoarseness, stomach-area pain, diarrhea, and weakness, lack of strength and energy and feeling very tired or sleepy (asthenia).

Zituvimet Oral Combo an Option for Adults with Type 2 Diabetes

This past month the FDA approved oral Zituvimet, a type 2 diabetes option from Zydus Pharmaceuticals. Zituvimet is a combination of 2 marketed drugs: sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin, a biguanide, used in addition to diet and exercise to improve glycemic (blood sugar) control in adults with type 2 diabetes.

• Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating.
• Zituvimet contains sitagliptin in the free base form. The metformin and sitagliptin phosphate combination was first approved in 2007 as the brand Janumet. Generic metformin is available in the US, but the first generic sitagliptin product is not expected until fall of 2026.
• Zituvimet tablets are taken orally twice daily with meals and come in 2 fixed-dose strengths: sitagliptin 50 mg / metformin 500 mg and sitagliptin 50 mg / metformin 1,000 mg.
• This product carries a Boxed Warning for lactic acidosis. Other warnings include pancreatitis, heart failure, acute renal failure, and vitamin B12 deficiency, among others. The most common side effects occurring in at least 5% of patients were diarrhea, upper respiratory tract infection, and headache.
• Zituvimet may provide a more affordable option for patients with type 2 diabetes, according to the manufacturer.

FDA Approves Ogsiveo as First Treatment for Rare, Noncancerous Tumors

In November, the FDA approved Ogsiveo (nirogacestat), an oral treatment for adults with progressing desmoid tumors who require systemic treatment. Ogsiveo is a selective, gamma-secretase inhibitor developed by SpringWorks Therapeutics.

• Desmoid tumors are aggressive, noncancerous tumors of the soft tissues that usually occur in the abdomen, arms and legs. Surgery is the first option, but the tumors often return and can invade nearby organs, which may cause debilitating pain and be life-threatening.
• Ogsiveo works by inhibiting the enzyme gamma-secretase which is believed to play a role in the growth of desmoid tumors.
• The recommended dosage is 150 mg orally twice daily until disease progression or unacceptable toxicity.
• Approval was based on the Phase 3 DeFi trial with 142 adults with progressing desmoid tumors not amenable to surgery. Results showed a significant 71% reduction in the risk of disease progression compared to placebo. Median progression-free survival was not reached in the Ogsiveo arm and was 15.1 months in the placebo arm. The objective response rate (ORR) was 41% (8% with placebo), with a 7% complete response rate in the Ogsiveo arm and 0% in the placebo arm. The median time to first response was 5.6 months with Ogsiveo and 11.1 months with placebo.
• Warnings include possible severe diarrhea, ovarian toxicity, liver toxicity, non-melanoma skin cancer, electrolyte disturbances, and harm to an unborn baby. In addition to laboratory abnormalities, common side effects in at least 15% of patients include diarrhea, rash, nausea, tiredness, mouth sores, headache, stomach pain, cough, hair loss, upper respiratory tract infection and shortness of breath.
• Ogsiveo is expected to be available via a specialty pharmacy in the first or second week of December.

Adzynma is the First Approved Treatment for cTTP, a Rare Blood Clotting Disorder

Adzynma (ADAMTS13, recombinant-krhn) from Takeda Pharmaceuticals is now approved as prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adults and children with congenital thrombotic thrombocytopenic purpura. (cTTP). Adzynma, given as a slow intravenous infusion by a healthcare provider, is the first FDA-approved therapeutic option for people with cTTP.

• cTTP is a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme. cTTP has both acute and chronic manifestations (including stroke and cardiovascular disease). Symptoms can be severe and include low platelet counts, hemolytic anemia, headaches, and stomach-area pain. If left untreated, acute TTP events can lead to death in over 90% of people.
• Adzynma is a man-made (recombinant) version of the ADAMTS13 protein and works by replacing the missing or defective ADAMTS13 enzyme. In a pharmacokinetic study, 23 patients who received a single 40 IU/kg intravenous infusion of Adzynma achieved a 4- to 5-fold increase in ADAMTS13 activity compared to traditional plasma-based treatments.
• In studies, no patient experienced an acute TTP event while receiving Adzynma prophylactic treatment (n=37), while there was one acute TTP event in a patient receiving plasma-based therapies (n=38). In addition, no subacute TTP events were reported in patients receiving Adzynma, compared to five subacute TTP events in four patients receiving plasma-based therapies. In the continuation period, two patients receiving Adzynma prophylaxis had two subacute events.
• Warnings include serious allergic reactions and development of neutralizing antibodies. The most common side effects occurring in at least 5% of patients were headache, diarrhea, migraine, stomach area pain, nausea, upper respiratory tract infection, dizziness and vomiting.

Posted November 2023

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