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2023 | 2022 FDA Drug Approvals | US Pharma News | iPharmaCenter

January 27, 2023

Keytruda, as an adjuvant treatment, is approved for Stage IB, II, or IIIA NSCLC patients.

Merck has announced that the US Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) as an adjuvant treatment after surgery and platinum-based chemotherapy. It is approved in patients with stage IB, II, or IIIA non-small cell lung cancer (NSCLC).

The FDA approval was based on the KEYNOTE-091 trial, in which Keytruda demonstrated improvement in disease-free survival versus placebo in NSCLC patients following surgical resection and platinum-based chemotherapy. This is the fifth indication in the NSCLC setting and the 34th overall indication in the US.

In the Phase 3 KEYNOTE-091 trial, investigator-assessed disease-free survival (DFS) is the primary endpoint. Keytruda reduced the risk of disease recurrence or death by 27% versus the placebo. The median DFS was 58.7 months in patients on Keytruda versus 34.9 months in patients on placebo.

Merck announced the safety profile in the KEYNOTE-091 trial is consistent with the existing one.


December 23, 2022

FDA approved Lunsumio, Roche's bispecific antibody, for follicular lymphoma

Roche announced that its bispecific antibody Lunsumio (mosunetuzumab) was approved for treating relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

Also read: Japan drug approvals

The approval was based on the pivotal phase II GO29781; an open-label dose-escalation study aimed to evaluate Lunsumio in patients with relapsed or refractory B-cell non-Hidgkin lymphoma. In patients who received at least two previous treatments, 80% achieved durable response rates, with 60% achieving complete remission.

Lunsumio has received accelerated approval based on the response rate. Complete approval will be based on the clinical benefit demonstrated in the confirmatory trial. Lunsumio is a CD20xCD3 T-cell engaging bi-specific antibody administered in fixed duration for cancers.

Also read: Prostate cancer

Follicular lymphoma is a common slow-growing cancer, a form of non-Hodgkin lymphoma. In 2022, in the US, nearly 13,000 new cases of follicular lymphoma were diagnosed.


December 22, 2022

Gilead received approval for its twice-yearly HIV treatment Sunlenca.

Gilead announced that the US Food and Drug Administration approved Sunlenca (lenacapavir), a twice-yearly treatment for treating multi-drug resistant human immunodeficiency virus infection.

Sunlenca is a capsid inhibitor, given in combination with other antivirals (ARV), and is approved for heavily treatment-experienced HIV patients. There is no cross-resistance reported with existing classes of HIV therapies.

Also read: Pharmaceutical deals and acquisitions

The approval was based on the Phase 2/3 CAPELLA trial, in which Sunlenca was tested in combination with a background regimen. At week 52, 83% of patients administered Sunlenca plus background therapy achieved an undetectable viral load.

Sunlenca received Breakthrough Therapy Designation for treating HIV-1 infection.


November 17, 2022

Tzield approved for delaying Stage 3 T1D in adults and pediatrics with Stage 2 T1D

Provention Bio announced that Tzield (teplizumab) was approved for delaying progression to Stage 3 type-1 diabetes (T1D) in adults and pediatrics of age eight years and older with Stage 2 type-1 diabetes (T1D). Tzield prevented the progression to stage 3 T1D by twenty-five months versus placebo.

Tzield is an anti-CD3-directed antibody for intravenous use and is the first immunomodulatory agent approved for preventing the progression of stage 2 diabetes.

The approval was based on a double-blind, placebo-controlled trial in patients with stage 2 type 1 diabetes. Tzield was administered via intravenous infusion for 14 days; the primary endpoint is the time from randomization to progression to stage 3 type 1 diabetes. After 51 months, 45% of patients on Tzield were diagnosed with stage 3 type 1 diabetes versus 72% of patients who received a placebo. There was a statistically significant difference between Tzield versus placebo.

The common adverse events are decreased levels of white blood cells, rash, and headache.

Patients who progress to stage 3 T1D require insulin for life, and stage 3 T1D might lead to diabetic ketoacidosis.


November 11, 2022

Imfinzi, Imjudo plus chemotherapy was approved for NSCLC in the US.

AstraZeneca announced that the US Food and Drug Administration approved Imfinzi (durvalumab), Imjudo (tremelimumab), plus chemotherapy combination for patients with Stave IV non-small cell lung cancer.

The approval was based on the POSEIDON Phase III trial; a global open-label study aimed to determine the efficacy of Imfinzi (durvalumab), Imjudo (tremelimumab), plus chemotherapy versus chemotherapy in the first-line setting in patients with metastatic non-small cell lung cancer.

Imfinzi plus five cycles of Imjudo plus four cycles of chemotherapy reduced the risk of death by 23% versus chemotherapy. 33% of patients on the Imfinzi combination were alive after two years versus 22% of patients on chemotherapy. The combination reduced the risk of disease progression by 28% versus chemotherapy. 25% of patients on combination were alive after three years versus 13.6% on chemotherapy.

In the US, lung cancer is the second most common cancer; it was estimated that nearly 236,000 patients would be diagnosed with it in 2022. Only 8% of patients are alive after five years of diagnosis because of the poor prognosis.


October 25, 2022

The US FDA approved Tecvayli for multiple myeloma.

Janssen Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli (teclistamab) for adult patients with refractory multiple myeloma. The drug is approved for patients previously treated with four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.

Tecvayli received accelerated approval based on response rate, and complete approval will be received upon verification of efficacy with confirmatory trials.

The accelerated approval was based on the Phase 2 MajesTEC-1 clinical trial, which recruited 110 patients treated with a median of five lines of therapy. Nearly 78% of patients were previously treated with four lines of treatment. The overall response rate (ORR) was 61.8%, and 28.2% showed a complete response. The median time for response was 1.2 months. At six months, the duration of response was 90.6%, and 66.5% at nine months.

Tecvayli is a bispecific T-cell engager antibody available in the subcutaneous form.


October 21, 2022

Rinvoq approved for non-radiographic axial spondyloarthritis, sixth indication approval in the US.

Rinvoq (upadacitinib) was approved for adults with active non-radiographic axial spondyloarthritis (nr-axSpA). Rinvoq is the first and only JAK inhibitor approved for nr-axSpA.

The approval was based on the Phase 3 SELECT-AXIS 2 trial, in which 44.9% of patients on Rinvoq achieved ASAS40 compared to 22.3% of patients on placebo at week 14. The efficacy was observed as early as the second week of the initiation of treatment.

Rinvoq can cause some severe adverse events. It might lead to severe infection by reducing the body's ability to fight infection; some might be fatal because of infections by tuberculosis (TB), bacteria, fungi, or viruses. It increases the death risk in patients 50 years and older with one or more heart disease risk factors. Further, it can increase the risk of cancers, including lymphoma and skin cancer. Patients with at least one risk factor of heart disease have increased chances of heart attack, stroke, and death. It also increases the chances of blood clots in these patients. It might also cause tears in the stomach or intestines.


October 12, 2022

FDA authorized the use of Pfizer and Moderna Bivalent COVID-19 vaccines as a booster dose for children down to five years.

The US Food and Drug Administration has authorized the use of Moderna and Pfizer COVID-19 vaccines as a booster dose in children who received primary vaccination. The Moderna COVID-19 vaccine is administered as a booster dose in children down to six years of age. Pfizer's COVID-19 vaccine is authorized for children down to five years of age.

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The bivalent vaccine has an mRNA component of the original strain which is common between omicron variant BA.4 and BA.5. The vaccine is protective against the COVID-19 virus. The mRNA stimulates the host cells to make spike proteins identical in BA.4 and BA.5.

Also read: Drug approvals in Japan

The monovalent Pfizer-BioNTech COVID-19 vaccine is now not authorized as a booster dose for children between the age of five to eleven years. The Moderna and Pfizer vaccines are authorized for primary vaccination in individuals six months and older.

Also read: Merck and Moderna agreed to develop and commercialize a cancer vaccine


October 07, 2022

US FDA approved Boostrix during pregnancy for preventing whooping cough in infants.

The United States Food and Drug Administration (FDA) approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed) in pregnant women for preventing whooping cough (pertussis) in infants younger than two months. Boostrix has to administer in the third trimester of pregnancy.

Also read: Drug approvals in Japan

The approval was based on the observational case-control study, and FDA found the real-world evidence appropriate for the approval. Boostrix was 78% effective in preventing whopping cough when administered during the third trimester of pregnancy.

The safety of Boostrix in the third trimester of pregnancy was assessed based on a randomized, placebo-controlled study in the ex-US population. It was observed to be safe, and FDA stated that since the formulation is the same, it was believed to be safe in the US population as the formulation contains the same components, except the percentage of aluminum is higher in the non-US formulation. There were no vaccine-related adverse events during pregnancy or in infants.

Also read: Australia Healthcare News

Pertussis is a respiratory illness that often has severe implications in babies. It was considered a common outbreak in the US. Hospitalizations and deaths are reported in infants younger than two months of age, and with the Boostrix vaccine, these infants get protected. Nearly 4.2% of pertussis cases in the US are reported in infants six months and younger, out of which almost 31% require hospitalization.


September 21, 2022

Retevmo was approved for adults with advanced or metastatic RET-positive solid tumors.

The US Food and Drug Administration approved Lilly's Retevmo (selpercatinib, 40 mg & 80 mg capsules) for rearranged during transfection (RET) gene fusion advanced or metastatic solid tumors. Retevmo was authorized for solid tumors under accelerated approval and was based on the overall response rate and duration of response. The continued approval will be based on the clinical benefit demonstrated in the confirmatory trial.

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The approval was based on the LIBRETTO-001 trial, in which the overall response rate was 44%, and the median duration of response was 24.5 months.

Retevmo was previously approved for RET fusion-positive non-small cell lung cancer (NSCLC), and RET-mutant medullary thyroid cancer (MTC).


August 12, 2022

FDA approved Xofluza to treat influenza in children