Several New Cancer Fighting Drugs Approved by the FDA

According to Merriam-Webster, the definition of cure is:
1a: to restore to health, soundness, or normality; 1b: to bring about recovery from; 2a: to deal with in a way that eliminates or rectifies.

Though researchers have not found the ‘cure’ for cancer, they are finding ways to treat all types of cancers in hopes of providing relief and hopefully remission to those who are facing treatments for this disease. The following are the newest drugs that have been approved by the FDA in recent months to treat various cancer types in hopes of providing relief or remission.

Copiktra (duvelisib) by Verastem was approved in September for the treatment of chronic lymphocytic leukemia, small lymphocytic lymphoma or follicular lymphoma.

Copiktra is specifically indicated for the treatment of adults with 1) relapsed or refractory chronic lymphocytic leukemia, 2) small lymphocytic lymphoma after at least two prior therapies and 3) relapsed or refractory follicular lymphoma after at least two prior systemic therapies.

Copiktra is supplied as a capsule for oral administration. The recommended dose is  25 mg administered as oral capsules twice daily (BID) with or without food in 28 day cycle. The capsules should be swallowed whole and not opened, broken, or chewed.

Side effects may include diarrhea or colitis, neutropenia (abnormally low count of a type of white blood cell), rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, anemia.

Daurismo (glasdegib) by Pfizer was approved in November for the treatment of newly-diagnosed acute myeloid leukemia in adults 75 years of age or older.

Daurismo is specifically indicated for use in combination with low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

Daurismo is supplied as a tablet for oral administration. The recommended dose of is 100 mg orally once daily on days 1 to 28 in combination with cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control. For patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response.

Daurismo can be taken with or without food and should be administered about the same time each day. Do not split or crush tablets. If a dose of Daurismo is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of Daurismo is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer two doses of Daurismo within 12 hours.

Daurismo does include a Black Box warning and symptoms may include anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, and decreased appetite to name a few.

Libtayo (cemiplimab-rwlc) from  Regeneron Pharmaceuticals was approved in September for the treatment of cutaneous squamous cell carcinoma.

Libtayo is specifically indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Libtayo is supplied as an intravenous solution with a recommended dosage of 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Side effects of Libtayo may include fatigue, rash, and diarrhea.

Lorbrena (lorlatinib) from Pfizer was approved in November for the treatment of ALK-positive metastatic non-small cell lung cancer.

Lorbrena is specifically indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer whose disease has progressed on 1) crizotinib and at least one other ALK inhibitor for metastatic disease; or 2) alectinib as the first ALK inhibitor therapy for metastatic disease; or 3) ceritinib as the first ALK inhibitor therapy for metastatic disease.

Lorbrena is supplied as a tablet for oral administration. The recommended dosage is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. Tablets should be swallowed whole and should not be chewed, crushed or split out. Tablets should not be ingested if they are broken, cracked, or otherwise not intact. Lorbrena should be administered at the same time each day. Do not take two doses at the same time to make up for a missed dose. Do not take an additional dose if vomiting occurs after Lorbrena but continue with the next scheduled dose.

Adverse effects associated of Lorbrena may include edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea.

Lumoxiti (moxetumomab pasudotox-tdf) from AstraZeneca was approved in September for the treatment of relapsed or refractory hairy cell leukemia.

Lumoxti is specifically indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

Lumoxiti is supplied as a solution for intravenous injection. The recommended dose of Lumoxiti is 0.04 mg/kg administered as a 30-minute intravenous infusion on Days 1, 3, and 5 of each 28-day cycle. Continue Lumoxiti treatment for a maximum of 6 cycles, disease progression, or unacceptable toxicity.

Adverse effects associated with the use of Lumoxiti may include infusion related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, diarrhea.

Poteligeo (mogamulizumab-kpkc) from Kyowa Kirin was approved in August for the treatment of mycosis fungoides or Sézary syndrome. Poteligeo is specifically indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

Poteligeo is supplied as a solution for intravenous administration. The recommended dose is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity. Administer Poteligeo within 2 days of the scheduled dose. If a dose is missed, administer the next dose as soon as possible and resume dosing schedule. Do not administer Poteligeo subcutaneously or by rapid intravenous administration.

Side effects associated with the use of Poteligeo may include rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, upper respiratory tract infection.

Talzenna (talazoparib) from; Pfizer was approved in October for the treatment of deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer,

Talzenna is specifically indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

Talzenna is supplied as a capsule for oral administration. The recommended dose of Talzenna is 1 mg taken orally once daily, with or without food. A 0.25 mg capsule is available for dose reduction. Patients should be treated until disease progression or unacceptable toxicity occurs. The capsule should be swallowed whole and must not be opened or dissolved. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.

Side effects associated with the use of Talzenna fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite.

Vitrakvi (larotrectinib) from Loxo Oncology was approved in November for the treatment of solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

Vitrakvi is specifically indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity, and; have no satisfactory alternative treatments or that have progressed following treatment.

Vitrakvi is supplied as both a capsule and an oral solution. The recommended dose regimen is dependent on the size of the patient and is provided orally twice daily, with or without food, until disease progression or until unacceptable toxicity.

Side effects associated with the use of Vitrakvi may include , fatigue, nausea, dizziness, vomiting, increased AST, cough, increased ALT, constipation diarrhea.

Vizimpro (dacomitinib) from Pfizer was approved in September 2018 for the treatment of metastatic non-small cell lung cancer.

Vizimpro is specifically indicated for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Vizimpro is supplied as a tablet for oral administration. The recommended dose is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. Vizimpro can be taken with or without food and should be administered at the same time each day. If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose.

Side effects may include diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, pruritus.

Xospata (gilteritinib) from Astellas was approved in November for the treatment of acute myeloid leukemia with a FLT3 mutation.

Xospata is specifically indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.

Xospata is supplied as a tablet for oral administration. The recommended starting dose is 120 mg orally once daily with or without food. Response may be delayed. In the absence of disease progression or unacceptable toxicity, treatment for a minimum of 6 months is recommended to allow time for a clinical response. Do not break or crush Xospata tablets. Administer tablets orally about the same time each day. If a dose of Xospata is missed or not taken at the usual time, administer the dose as soon as possible on the same day, and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses within 12 hours.

Side effects associated with the use of Xospata may include myalgia/arthralgia, transaminase, increase, fatigue/malaise, fever, noninfectious diarrhea, dyspnea, edema, rash, pneumonia, nausea, stomatitis, cough, headache, hypotension, dizziness, and vomiting.