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Summary of
ratifications1
Nivolumab in combination with chemotherapy and nivolumab in combination with ipilimumab are approved as first-line indications for esophageal squamous cell carcinoma (ESCC).
Dabrafenib combined with trametinib accelerates the approval for the treatment of BRAF V600E mutant unresectable or metastatic solid tumors
3Duvalumab in combination with chemotherapy is approved as a first-line indication for locally advanced or metastatic biliary cancer (BTC).
4
Sepputinib is approved for accelerated treatment of locally advanced or metastatic solid tumors with positive RET gene fusion
5Futibatinib is approved for the treatment of previously treated, unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusion or rearrangement
6Tremelimumab and durvalumab are approved as first-line indications for unresectable hepatocellular carcinoma (HCC).
FDA approves capecitabine for drug label updates
2022
The FDA approved nivolumab in combination with fluoropyrimidine and platinum-based chemotherapy, and nivolumab plus ipilimumab as first-line treatment
for advanced or metastatic esophageal squamous cell carcinoma (ESCC).
The approval is primarily based on a randomized controlled, open-label, phase III CheckMate-648 study of 970 previously
untreated patients with unresectable advanced, recurrent, or metastatic ESCC.
Patients are randomly (1:1:1) assigned to receive the following treatments:
nivolumab 240 mg, D1 and D15; 5-FU 800 mg/m²，d1-5； cisplatin 80 mg/m², d1; q4w；
nivolumab 3 mg/kg, q2 W; ipilimumab 1 mg/kg, q6w;
5-FU 800 mg/m²，d1-5； cisplatin 80 mg/m², d1; q4w；
The primary efficacy endpoints of the study were overall survival (OS) and progression-free survival (PFS)
as assessed by the Independent Centre for Blinding (BICR).
Results showed a significant benefit of OS in the nivolumab + chemotherapy group compared with chemotherapy alone in the overall population (13.
2 months vs.
10.
7 months; HR=0.
74; 95% CI, 0.
61-0.
90; p=0.
0021), and there was also a significant OS benefit in the nivolumab + ipilimumab group (12.
8 months vs.
10.
7 months; HR=0.
78；95%CI，0.
65-0.
95；p=0.
0110）
。
Among patients with a PD-L1 score of ≥1%, there was still a significant OS benefit
in the nivolumab + chemotherapy group (HR=0.
54; 95% CI, 0.
41-0.
71; p<0.
0001) and nivolumab + ipilimumab (HR=0.
64; 95% CI, 0.
49-0.
84; p=0.
0010) compared with chemotherapy alone.
Among the most common (≥20%) adverse reactions in the nivolumab + chemotherapy group included nausea, decreased appetite, fatigue, constipation, stomatitis, diarrhea, and vomiting, and the most common (≥20%) adverse reactions in the nivolumab + ipilimumab group included rash, fatigue, fever, nausea, diarrhea, and constipation
.
The recommended dose for the regimen is: (1) nivolumab 240 mg q2 w or 480 mg q4 w with fluoropyrimidine and platinum-based chemotherapy; (2) Nivolumab 3 mg/kg q2w or 360 mg q3w, combined with ipilimumab 1 mg/kg q6w
.
22, 2022
FDA accelerated approval of dabrafenib in combination with trametinib for the treatment of patients with unresectable or metastatic solid tumors with BRAF V600E mutations in adults or children ≥6 years of age who have progressed to disease after prior treatment and no alternative treatment
regimens.
Of note, due to inherent resistance to BARF inhibitors, this regimen is not suitable for colorectal cancer (CRC) patients, and in addition, dabrafenib is not suitable for BRAF wild-type solid tumor patients
.
The accelerated approval is based on BRF117019, NCI-MATCH, CTMT212X2101, COMBI-d, COMBI-v and BRF113928 and other studies, click the link to view the approval details: Summer Inventory | A list of FDA drug and protocol approvals in the field of solid tumors from June to August.
In the National Comprehensive Cancer Network (NCCN) guidelines for the diagnosis and treatment of hepatobiliary carcinoma, this treatment strategy is recommended as an optional strategy for the second-line treatment of BRAF V600E mutant BTC; In the NCCN guidelines for the diagnosis and treatment of pancreatic cancer, this treatment strategy is recommended as an alternative strategy for first-line and second-line treatment of patients with BRAF V600E mutation
.
The recommended dose of dabrafenib for adults is 150 mg orally, BID; Trametinib 2 mg, orally, qd
.
The recommended dose for pediatric patients is based on body weight, and the recommended dose for patients weighing < 26 kg has not been established<b11>.
9
FDA approved durvalumab in combination with gemcitabine and cisplatin for the treatment of adult patients
with locally advanced or metastatic BTC.
The approval is based on a randomized, double-blind, placebo-controlled, multi-regional phase III TOPAZ-1 study of 685 histologically confirmed patients with locally advanced unresectable or metastatic BTC who had not previously received systemic therapy
for advanced disease.
Among the included patients, 56% of the patients were intrahepatic cholangiocarcinoma, 25% of gallbladder cancer, and 19% of extrahepatic cholangiocarcinoma, and patients were randomly (1:1) assigned to receive the following treatments:
Duvalumab 1500 mg, d1; gemcitabine 1000 mg/m², cisplatin 25 mg/m², d1 and d8; Q21D, up to 8 cycles; sequential davalumab 1500 mg, q4 W;
placebo 1500 mg, d1; gemcitabine 1000 mg/m², cisplatin 25 mg/m², d1 and d8; Q21D, up to 8 cycles; sequential placebo for Q4W;
Duvalumab or placebo is continued until disease progression or toxicity is unacceptable
.
If the patient is clinically stable and has a clinical benefit, treatment as determined by the investigator is allowed after disease progression
.
The primary efficacy endpoint of the study was OS, and results showed a significant improvement
in OS in patients in the durvalumab + chemotherapy group compared with placebo + chemotherapy.
The median OS of durvalumab + chemotherapy and placebo + chemotherapy was 12.
8 months and 11.
5 months, respectively (HR=0.
80; 95% CI, 0.
66-0.
97; p=0.
021), median PFS was 7.
2 months and 5.
7 months, respectively, and the overall response rate (ORR) assessed by the investigators was 27% and 19%, respectively
。
The most common (≥20%) adverse reactions in patients include fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and fever
.
For patients weighing ≥ 30 kg, the recommended dose for this regimen is durvalumab 1500 mg plus chemotherapy Q3 W and sequential davalumab monotherapy 1500 mg Q4 W until disease progression or unacceptable
toxicity.
For patients weighing < 30 kg, the recommended dose for this regimen is durvalumab 20 mg/kg plus chemotherapy q3 W and sequential duvalumab monotherapy 20 mg/kgq4 W until disease progression or unacceptable
toxicity.
9
FDA accelerates approval of the Ceplitinib Extended Indication for the treatment of patients
with locally advanced or metastatic solid tumors who carry positive RET gene fusions.
These patients have progressed during or after previous systemic therapy, or there are no other satisfactory alternatives
This accelerated approval is primarily based on the Phase I/II LIBRETTO-001 trial, please click on the link to view the approval details: FDA Alert| Selpercatinib Accelerated Approval for RET Gene Fusion-Positive Locally Advanced or Metastatic Solid Tumors
.
In the NCCN guidelines for the diagnosis and treatment of colon and rectal cancer, this treatment strategy is labeled as an optional strategy for patients with positive NTRK gene fusion.
In the NCCN guidelines for the diagnosis and treatment of hepatobiliary carcinoma, this treatment strategy is recommended as the second-line treatment of NTRK gene fusion-positive HCC, as well as the alternative strategy for first- and second-line treatment of BTC patients.
In the NCCN guidelines for the diagnosis and treatment of pancreatic cancer, this treatment strategy is recommended as an option for patients with NTRK gene fusion and good PS
scores.
For patients with a body weight of < 50 kg, the recommended dose of seputinib is 120 mg, bid; For patients with a body weight of ≥ 50 kg, <b10>the recommended dose of seputinib is 160 mg, bid
.
9
FDA accelerated approval offutibatinib for the treatment of previously treated, unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma
with FGFR2 gene fusion or rearrangement.
The approval is based on the multicenter, open-label, single-arm TAS-120-101 study of 103 previously treated patients with unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma who carry FGFR2 gene fusion or rearrangement
confirmed by next-generation sequencing.
Patients take futibatinib20 mg orally daily until disease progression or toxicity is intolerable
.
The primary efficacy endpoints of the study were BICR to determine the ORR assessed and duration of response (DoR)
according to RECIST v1.
1.
The results showed that the ORR of the patients was 42%, all were partial remission (PR), and the median DoR of patients was 9.
7 months
.
The most common (≥20%) adverse reactions in patients include nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, taste disturbance, dry eye, nausea, decreased appetite, urinary tract infection, hand-foot syndrome, and vomiting
.
The recommended dose of the regimen is futibatinib20 mg orally, qd, until disease progression or intolerability
of toxicity.
10
The FDA approved tremelimumab in combination with durvalumab for use in adult patients
with unresectable uHCC.
THE APPROVAL IS PRIMARILY BASED ON THE HIMALAYA STUDY, CLICK ON THE LINK TO SEE THE APPROVAL DETAILS: FDA LETTERS| TREMELIMUMAB IN COMBINATION WITH DUVALUMAB APPROVED FOR UNRESECTABLE HEPATOCELLULAR CARCINOMA
.
For patients weighing ≥ 30 kg, the recommended dose of this regimen is tremelimumab 300 mg, IV, D1, and durvalumab 1500 mg, IV, D1 combination, followed by durvalumab 1500 mg, IV, Q4W
。 For patients weighing < 30 kg, the recommended dose for this regimen is tremelimumab 4 mg/kg, IV, D1, and durvalumab 20 mg/kg, IV, D1 combination, followed by durvalumab 20 mg/kg, IV, Q4W<b11>.
12
The FDA approved capecitabine for label renewal in the Oncology Center of Excellence (OCE) program, the first drug
in the pilot program to receive a label update.
The project aims to update the label information of certain older oncology drugs to ensure the clinical significance and scientific validity of this label information
.
For digestive tumors, capecitabine is an important part of several treatment regimens, and it is now approved for the following indications for digestive tumors:
as a single-agent regimen or in combination chemotherapy regimen for adjuvant therapy in patients with stage III colon cancer;
for perioperative chemoradiotherapy in patients with locally advanced rectal cancer;
as a monotherapy regimen or in combination chemotherapy for the treatment of patients with unresectable or metastatic colorectal cancer;
as a combination chemotherapy regimen for the treatment of patients with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer;
As a combination chemotherapy regimen for the treatment of previously untreated HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma;
as a combination chemotherapy regimen for adjuvant therapy in patients with pancreatic cancer;
Editor: Babel
Reviewed: Faline
Typesetting: Babel
Execution: Babel
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