In the first half of 2021, the U.S. FDA approved a total of 29 innovative drugs, of which 27 were new molecular entities and new biologics approved by the Center for Drug Evaluation and Research (CDER) and the remaining two were Car-T therapies (Abecma and Breyanzi) approved by the Center for Biologics Evaluation and Research (CBER).

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New Drug Approvals & Upcoming FDA
Approvals 2021
In the first half of 2021, the U.S. FDA approved a total of 29 innovative drugs, of which
27 were new molecular entities and new biologics approved by the Center for Drug
Evaluation and Research (CDER) and the remaining two were Car-T therapies (Abecma
and Breyanzi) approved by the Center for Biologics Evaluation and Research (CBER). It is
worth mentioning that the number of 27 new drugs approved by CDER in the first half of
the year has reached a record high for the same period in the last decade.
Drug Approvals in first half of 2021, Image Source: https://www.fiercepharma.com/

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Potential Blockbusters Approved In 2021
Below, find summaries of several high-profile approvals that have come so far in 2021.
Potential Blockbusters Approved In 2021, image source: Evaluate Pharma
Aduhelm (Aducanumab)
On June 7, 2021, the FDA announced the accelerated approval of Aduhelm
(aducanumab), a monoclonal antibody developed by Biogen, for the treatment of
Alzheimer's disease (AD). This is the first FDA approval of a new therapy for
Alzheimer's disease in nearly 20 years, and the first FDA-approved new therapy
targeting the underlying disease mechanism of AD. Previously, Aduhelm was also granted
Fast Track status by the FDA.
However, even though Aduhelm has been approved, it is still mired in the great
controversy.
First, the approval has generated controversy focused on the therapeutic effects of
Aduhelm. The agency used the removal of amyloid plaque (a possible cause of
Alzheimer's disease) as a surrogate endpoint, rather than approving based on hard data
showing a clinical benefit in terms of slowing cognitive decline. The agency allotted the
company a window of nine years to conduct a follow-up trial to determine whether the

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drug actually does benefit patients' daily lives. There is also the risk of delisting the drug if
it does not work as expected.
In addition, questions have been raised about the high pricing of Aduhelm, which Biogen
announced after its approval at $56,000 per year, well above previous projections by
some industry analysts and advisory groups. Some industry analysts said that Aduhelm
would most likely result in a significant increase in Medicare spending. Other industry
analysts said the excessive price could further spur regulatory scrutiny of the drug's
pricing. Under much pressure and criticism, the U.S. House Committee on Oversight and
Reform took the position on June 25 that it would investigate the FDA's approval of
Aduhelm and its pricing.
Abecma (Ide-cel)
Just about a month after Bristol Myers Squibb's high-profile CAR-T approval for
lymphoma med Breyanzi, the company ushered another highly anticipated cell therapy
(Abecma) across the FDA finish line.
Abecma (idecabtagenevicleucel; ide-cel), co-developed by Bristol-Myers Squibb and
bluebird, is the first FDA-approved CAR-T therapy targeting BCMA and the fifth
CAR-T therapy approved worldwide.
FDA-approved CAR-T therapies, image source: Evaluate Pharma
BCMA is an extremely important B-cell biomarker that is widely present on the surface of
multiple myeloma cells and has become a very popular immunotherapeutic target for
multiple myeloma and other hematologic malignancies in recent years. As an anti-BCMA
CAR-T cell therapy, Abecma recognizes and binds to the BCMA protein on MM cancer
cells, resulting in the death of BCMA-expressing cancer cells.
The FDA's approval was based on data from a pivotal Phase II clinical study code-named
KarMMa. The study enrolled 127 patients with relapsed/refractory multiple myeloma who
had received at least three prior lines of therapy including immunomodulators,
proteasome inhibitors and anti-CD38 antibodies. The results of the study showed an
overall remission rate (ORR) of 72% (95% CI: 62-81) in 100 patients with evaluable

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efficacy, with 28% achieving strict complete remission (sCR, 95% CI: 19%-38%). The
median duration of remission was 30 days for all patients who produced a response, with
a median duration of remission of 11 months (95% CI: 10.3-11.4) and 19 months for
patients who achieved sCR.
Breyanzi (Liso-cel)
Diffuse large B-cell lymphoma (DLBCL) is the most common malignant lymphoma
worldwide and an aggressive form of non-Hodgkin's lymphoma (NHL). 30-40% of patients
with DLBCL do not achieve remission after first-line therapy or have relapsed disease.
Patients who are unable to receive first-line therapy and are not candidates for high-dose
chemotherapy (HDC) and autologous stem cell transplantation (ASCT) have a poor
prognosis and are in urgent need of additional treatment options.
Breyanzi (lisocabtagene maraleucel), developed by Juno Therapeutics, a division of
Bristol-Myers Squibb (BMS), is a CAR-T cell therapy that targets the CD19 antigen and is
the fourth CAR-T therapy approved for marketing by the FDA. It was granted
Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy
Designation (RMAT) by the FDA.​
This therapy is unique in that the ratio of CD8-positive to CD4-positive T cells in CAR-T
therapy is controlled, allowing for better control of the toxic effects of cell therapy.
Lumakras（sotorasib）
Lumakras (sotorasib, AMG 510), developed by Amgen, is the world's first approved
oncology treatment to target KRAS mutations.
The FDA's accelerated approval was based on the results of a Phase I/II clinical study
code-named CodeBreaK 100. Among 124 NSCLC patients with progressive KRAS G12C
mutations who had received prior chemotherapy and/or immunotherapy for disease
progression, sotorasib achieved an objective remission rate (ORR) of 36%, with 58% of
patients in sustained remission for ≥6 months.
Lupkynis (voclosporin)
The FDA has approved LUPKYNISTM (voclosporin) in combination with a background
immunosuppressive therapy regimen to treat adult patients with active lupus nephritis
(LN). LUPKYNIS is the first FDA-approved oral therapy for LN.
The FDA based its approval on results from the phase 3 AURORA trial and phase 2
AURA-LV trial. A total of 553 adults with biopsy-confirmed lupus nephritis were
randomized 1-to-1 to receive either 23.7 mg Lupkynis or placebo twice daily alongside
standard therapy. In addition, all patients received concurrent mycophenolate mofetil at a
target dose 2 g/day.
Zynlonta (loncastuximab tesirine-​ lpyl)
Zynlonta is the first single-agent CD19-targeted antibody drug against diffuse large
B-cell lymphoma (DLBCL ).

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Like other new DLBCL drugs, Zynlonta is approved for patients who have failed two prior
systemic therapies. Unlike its competitors, however, Zynlonta requires dosing every three
weeks.
In a phase 2 trial, Zynlonta had an overall response rate of 48.3%, and for those patients
who did respond, the median duration of response was 10.3 months. More than 24% of
patients in the trial achieved a complete response. Following approval, ADC utilized its
clinical manufacturing partner, Avid Bioservices, to help manufacture commercial supplies.
A vial of the drug reportedly cost $23,500 before rebates or discounts.
Cabenuva
Cabenuva started a new chapter for HIV treatment. Rather than daily oral pills, the
two-drug injectable offers the first complete long-acting HIV regimen that's given once a
month. A combination of GSK's cabotegravir and Johnson & Johnson's rilpivirine, the
intramuscular therapy showed it could match up to traditional three-drug regimens at
suppressing HIV in two phase 3 trials. The drug faced a previous setback at the FDA
thanks to manufacturing-related issues, making Canada the first country to approve it last
March.
Meanwhile, GSK's ViiV Healthcare is awaiting an FDA decision to reduce Cabenuva’s
dosing frequency to once every two months.
Upcoming FDA Approvals 2021
In fact, a review of Evaluate Vantage's "biggest potential new launches in 2021" released
in January shows that only four have been approved by the halfway point of 2021 –
Aduhelm, Abecma, Breyanzi. The table below reviews the progress of the assets in that
original article that are still awaiting regulatory verdicts.

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